SURGVIEW INTEGRATED VISUALIZATION SYSTEM

Arthroscope

BIOVISION TECHNOLOGIES, LLC

The following data is part of a premarket notification filed by Biovision Technologies, Llc with the FDA for Surgview Integrated Visualization System.

Pre-market Notification Details

Device IDK082293
510k NumberK082293
Device Name:SURGVIEW INTEGRATED VISUALIZATION SYSTEM
ClassificationArthroscope
Applicant BIOVISION TECHNOLOGIES, LLC 221 CORPORATE CIRCLE SUITE H Golden,  CO  80401
CorrespondentDawn M Tibodeau
TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton,  MN  55112 -1891
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2008-08-12
Decision Date2008-09-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851582006177 K082293 000
00841036135010 K082293 000
00851582006023 K082293 000
00851582006085 K082293 000
00851582006092 K082293 000
00851582006122 K082293 000
00851582006139 K082293 000
00851582006146 K082293 000
00851582006153 K082293 000
00851582006160 K082293 000
00841036130244 K082293 000

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