GORE SMOOTHER II AND GORE BPTB

Arthroscope

W.L. GORE & ASSOCIATES,INC

The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore Smoother Ii And Gore Bptb.

Pre-market Notification Details

Device IDK941269
510k NumberK941269
Device Name:GORE SMOOTHER II AND GORE BPTB
ClassificationArthroscope
Applicant W.L. GORE & ASSOCIATES,INC 1500 N. FOURTH ST. P.O. BOX 3000 Flagstaff,  AZ  86003
ContactLarry J Kovach
CorrespondentLarry J Kovach
W.L. GORE & ASSOCIATES,INC 1500 N. FOURTH ST. P.O. BOX 3000 Flagstaff,  AZ  86003
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-03-16
Decision Date1994-05-19

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