The following data is part of a premarket notification filed by Leonard Medical, Inc. with the FDA for Small Joint Hand Instruments.
| Device ID | K895685 |
| 510k Number | K895685 |
| Device Name: | SMALL JOINT HAND INSTRUMENTS |
| Classification | Arthroscope |
| Applicant | LEONARD MEDICAL, INC. 1464 HOLCOMB RD. Huntingdon Valley, PA 19006 |
| Contact | Leonard J Bonnell |
| Correspondent | Leonard J Bonnell LEONARD MEDICAL, INC. 1464 HOLCOMB RD. Huntingdon Valley, PA 19006 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-22 |
| Decision Date | 1989-10-16 |