510(k) clearances

Sutil Rich Personal Lubricant

Hathor Professional Skincare , Ltd. · Obstetrics/Gynecology

K250629Substantially EquivalentTraditionalNUC
Open FDA's page for this record
Third party flag
N
City
Victoria
Advisory committee description
Obstetrics/Gynecology
Address 1
2618 Roseberry Ave.
Statement or summary
Summary
Product code
NUC
Zip code
V8R 3T7
Applicant
Hathor Professional Skincare , Ltd.
Decision date
2025-05-02
Decision code
SESE
Country code
CA
Device name
Sutil Rich Personal Lubricant
Advisory committee
OB
Contact
Carolyn (Mellta) Swift
K number
K250629
Date received
2025-03-03
Review advisory committee
OB
Postal code
V8R 3T7
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Lubricant, Personal
Medical specialty description
Obstetrics/Gynecology
Regulation number
884.5300
Device class
2
Registration number
3045006668, 3004079477, 3008469990, 3010165308, 3012477715, 3013474580, 1417367, 2022474, 3009939047, 3019444078, 3029905133, 3042254987, 3020512730, 3031885960, 3003896222, 3005113602, 3012194887, 3019880009, 3007067755, 3010142145, 3009599096, 3010409218, 3040301765, 3013441423, 1222115, 3011015568, 3010408703, 2531449, 3003631744, 3012262584, 3015538858, 3010419931, 3004089975, 1063707, 3014317667, 2650087, 3008808138, 2020372, 3004569514, 3013961642 +86 more
FEI number
3045006668, 3004079477, 3002806986, 3008469990, 3010165308, 3012477715, 3013474580, 2022474, 3009939047, 3019444078, 3029905133, 3042254987, 3020512730, 3031885960, 3005113602, 3012194887, 1000657351, 3007067755, 3040301765, 3009599096, 3010409218, 3010687142, 3013441423, 1222115, 3011015568, 3010408703, 3003631744, 3012262584, 3015538858, 3010419931, 3004089975, 3014317667, 2650087, 3008808138, 2020372, 3004569514, 3013961642, 3003446042, 3002808272, 3014759506 +86 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.