The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Ar-8200 Shaver System.
| Device ID | K932699 |
| 510k Number | K932699 |
| Device Name: | ARTHREX AR-8200 SHAVER SYSTEM |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | ARTHREX, INC. 3050 NORTH HORSESHOE DR. SUITE 200 Naples, FL 33942 |
| Contact | Baltz, Jr |
| Correspondent | Baltz, Jr ARTHREX, INC. 3050 NORTH HORSESHOE DR. SUITE 200 Naples, FL 33942 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-03 |
| Decision Date | 1994-01-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888867239432 | K932699 | 000 |
| 00888867123649 | K932699 | 000 |
| 00888867043305 | K932699 | 000 |
| 00888867043275 | K932699 | 000 |
| 00888867043244 | K932699 | 000 |
| 00888867043237 | K932699 | 000 |
| 00888867043220 | K932699 | 000 |
| 00888867043190 | K932699 | 000 |
| 00888867043183 | K932699 | 000 |
| 00888867043145 | K932699 | 000 |
| 00888867123854 | K932699 | 000 |
| 00888867123960 | K932699 | 000 |
| 00888867123977 | K932699 | 000 |
| 00888867222823 | K932699 | 000 |
| 00888867215702 | K932699 | 000 |
| 00888867215696 | K932699 | 000 |
| 00888867215689 | K932699 | 000 |
| 00888867215672 | K932699 | 000 |
| 00888867215665 | K932699 | 000 |
| 00888867212626 | K932699 | 000 |
| 00888867211841 | K932699 | 000 |
| 00888867211834 | K932699 | 000 |
| 00888867043138 | K932699 | 000 |