HENKE SASS WOLF OF AMERICA ARTHROSCOPE

Arthroscope

HENKE SASS WOLF OF AMERICA, INC.

The following data is part of a premarket notification filed by Henke Sass Wolf Of America, Inc. with the FDA for Henke Sass Wolf Of America Arthroscope.

Pre-market Notification Details

Device IDK080560
510k NumberK080560
Device Name:HENKE SASS WOLF OF AMERICA ARTHROSCOPE
ClassificationArthroscope
Applicant HENKE SASS WOLF OF AMERICA, INC. 106 EAST 5TH AVENUE Mount Dora,  FL  32757
ContactLynette Howard
CorrespondentLynette Howard
HENKE SASS WOLF OF AMERICA, INC. 106 EAST 5TH AVENUE Mount Dora,  FL  32757
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-02-28
Decision Date2008-03-18
Summary:summary

NIH GUDID Devices

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