510(k) K221875

Sterilization Pouch and Roll by Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. — Product Code FRG

K221875 is an FDA 510(k) premarket notification submitted by Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. for the device "Sterilization Pouch and Roll". The FDA issued a decision of Substantially Equivalent on Feb 13, 2023. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 13, 2023
Date Received
Jun 28, 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
510(k)