The following data is part of a premarket notification filed by F.m. Wiest Usa, Inc. with the FDA for Arthro Automat 5002.
| Device ID | K871180 |
| 510k Number | K871180 |
| Device Name: | ARTHRO AUTOMAT 5002 |
| Classification | Arthroscope |
| Applicant | F.M. WIEST USA, INC. 1301 N. KINGS HIGHWAY Cherry Hill, NJ 08034 |
| Contact | Wayne W Disanza |
| Correspondent | Wayne W Disanza F.M. WIEST USA, INC. 1301 N. KINGS HIGHWAY Cherry Hill, NJ 08034 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-25 |
| Decision Date | 1987-09-29 |