510(k) clearances

Sterilization Pouches and Reels

Shanghai Jianzhong Medical Packaging Co., Ltd. · General Hospital

K242898Substantially EquivalentTraditionalFRG
Open FDA's page for this record
Third party flag
N
City
Shanghai
Advisory committee description
General Hospital
Address 1
Bldg. 16, 789# Puxing Rd., Minhang District
Statement or summary
Summary
Product code
FRG
Zip code
200241
Applicant
Shanghai Jianzhong Medical Packaging Co., Ltd.
Decision date
2025-02-21
Decision code
SESE
Country code
CN
Device name
Sterilization Pouches and Reels
Advisory committee
HO
Contact
Xinhua Wei
K number
K242898
Date received
2024-09-23
Review advisory committee
HO
Postal code
200241
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Wrap, Sterilization
Medical specialty description
General Hospital
Regulation number
880.6850
Device class
2
Registration number
1051614, 3010363542, 9610612, 9616088, 3018094310, 3027234828, 3013298431, 1527185, 3002579136, 3004122598, 2437780, 3018781093, 3015058854, 3042191618, 3005599545, 3014421917, 1032227, 2029015, 3005180920, 2523664, 3005748481, 3042285072, 3036622014, 1055236, 3004362278, 3036679484, 3006425876, 3021361802, 3016761372, 3010864832, 3006400329, 3012315097, 3019848304, 3043226252, 9611959, 8022129, 3004634710, 3008770655, 2032364, 3007034244 +157 more
FEI number
1051614, 3010363542, 3018094310, 3027234828, 3003323921, 3013298431, 1527185, 3002579136, 3004122598, 1000160458, 1000110722, 3002805559, 3015058854, 3005599545, 3018781093, 3042191618, 3014421917, 1032227, 3005180920, 2523664, 3005748481, 3042285072, 2523865, 3036622014, 3004362278, 3036679484, 3006425876, 3021361802, 3016761372, 3006400329, 6499, 3012315097, 3019848304, 3043226252, 3001236905, 3004634710, 3008770655, 3007034244, 3004201548, 3038138452 +157 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.