The following data is part of a premarket notification filed by Arthropedics, Inc. with the FDA for Arthroscopic Retention-manipulation System (arms).
| Device ID | K873619 |
| 510k Number | K873619 |
| Device Name: | ARTHROSCOPIC RETENTION-MANIPULATION SYSTEM (ARMS) |
| Classification | Arthroscope |
| Applicant | ARTHROPEDICS, INC. 111 LESTER ST. Wallington, NJ 07057 |
| Contact | Jerry Procopio |
| Correspondent | Jerry Procopio ARTHROPEDICS, INC. 111 LESTER ST. Wallington, NJ 07057 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-08 |
| Decision Date | 1988-01-14 |