CARAPACE STERILE CAST PADDING

Component, Cast

CARAPACE, INC.

The following data is part of a premarket notification filed by Carapace, Inc. with the FDA for Carapace Sterile Cast Padding.

Pre-market Notification Details

Device IDK931672
510k NumberK931672
Device Name:CARAPACE STERILE CAST PADDING
ClassificationComponent, Cast
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 CodeLGF  
CFR Regulation Number888.5940 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-06
Decision Date1993-12-15

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