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 |