510(k) K223600

Sterilization Wrap by Wuhan Zonsen Medical Products Co., Ltd. — Product Code FRG

K223600 is an FDA 510(k) premarket notification submitted by Wuhan Zonsen Medical Products Co., Ltd. for the device "Sterilization Wrap". The FDA issued a decision of Substantially Equivalent on August 25, 2023. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Wuhan Zonsen Medical Products Co., Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2023
Date Received
December 2, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type