The following data is part of a premarket notification filed by Leonard Medical, Inc. with the FDA for Leonard Arm - Support Arm - Endoscopic Accessory.
| Device ID | K951854 |
| 510k Number | K951854 |
| Device Name: | LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY |
| Classification | Table, Operating-room, Ac-powered |
| 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 | FQO |
| CFR Regulation Number | 878.4960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-21 |
| Decision Date | 1995-06-21 |