CARAFLEX ELASTIC POLYMER PLASTER BANDA

Bandage, Cast

CARAPACE, INC.

The following data is part of a premarket notification filed by Carapace, Inc. with the FDA for Caraflex Elastic Polymer Plaster Banda.

Pre-market Notification Details

Device IDK813219
510k NumberK813219
Device Name:CARAFLEX ELASTIC POLYMER PLASTER BANDA
ClassificationBandage, Cast
Applicant CARAPACE, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeITG  
CFR Regulation Number890.3025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-11-09
Decision Date1981-12-17

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