The following data is part of a premarket notification filed by Biovision Technologies, Llc with the FDA for Surgview Integrated Visualization System.
Device ID | K082293 |
510k Number | K082293 |
Device Name: | SURGVIEW INTEGRATED VISUALIZATION SYSTEM |
Classification | Arthroscope |
Applicant | BIOVISION TECHNOLOGIES, LLC 221 CORPORATE CIRCLE SUITE H Golden, CO 80401 |
Correspondent | Dawn M Tibodeau TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2008-08-12 |
Decision Date | 2008-09-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
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 |