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510(k) K191131

Solidence Multipockets by Solidence Surgical Corporation — Product Code FRG

K191131 is an FDA 510(k) premarket notification submitted by Solidence Surgical Corporation for the device "Solidence Multipockets". The FDA issued a decision of Substantially Equivalent on Aug 3, 2022. 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
Aug 3, 2022
Date Received
Apr 29, 2019
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)

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FDA data resources