SWISSTEK 2000(TM) CAST REMOVAL SYSTEM

Instrument, Cast Removal, Ac-powered

CARAPACE, INC.

The following data is part of a premarket notification filed by Carapace, Inc. with the FDA for Swisstek 2000(tm) Cast Removal System.

Pre-market Notification Details

Device IDK932653
510k NumberK932653
Device Name:SWISSTEK 2000(TM) CAST REMOVAL SYSTEM
ClassificationInstrument, Cast Removal, Ac-powered
Applicant CARAPACE, INC. 2701 W CONCORD ST. Broken Arrow,  OK  74012
ContactJerry W Myers
CorrespondentJerry W Myers
CARAPACE, INC. 2701 W CONCORD ST. Broken Arrow,  OK  74012
Product CodeLGH  
CFR Regulation Number888.5960 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-06-02
Decision Date1994-01-28

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