VARIOUS DISPOSABLE KITS/TRAYS/INSTRU

Tray, Surgical, Instrument

CARAPACE, INC.

The following data is part of a premarket notification filed by Carapace, Inc. with the FDA for Various Disposable Kits/trays/instru.

Pre-market Notification Details

Device IDK840976
510k NumberK840976
Device Name:VARIOUS DISPOSABLE KITS/TRAYS/INSTRU
ClassificationTray, Surgical, Instrument
Applicant CARAPACE, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeFSM  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-03-06
Decision Date1984-05-31

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