STAPLE INSERTER-EXTRACTOR FOR ARTHROS

Staple Driver

INSTRUMENT MAKAR, INC.

The following data is part of a premarket notification filed by Instrument Makar, Inc. with the FDA for Staple Inserter-extractor For Arthros.

Pre-market Notification Details

Device IDK830456
510k NumberK830456
Device Name:STAPLE INSERTER-EXTRACTOR FOR ARTHROS
ClassificationStaple Driver
Applicant INSTRUMENT MAKAR, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHXJ  
CFR Regulation Number888.4540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-02-09
Decision Date1983-03-09

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