The following data is part of a premarket notification filed by Andronic Devices, Ltd. with the FDA for Kaps Positioning Arm.
| Device ID | K935381 |
| 510k Number | K935381 |
| Device Name: | KAPS POSITIONING ARM |
| Classification | Operating Room Accessories Table Tray |
| Applicant | ANDRONIC DEVICES, LTD. 140-13120 VANIER PLACE Richmond,b.c. Canada, CA V6v2j2 |
| Contact | Robert Macneil |
| Correspondent | Robert Macneil ANDRONIC DEVICES, LTD. 140-13120 VANIER PLACE Richmond,b.c. Canada, CA V6v2j2 |
| Product Code | FWZ |
| CFR Regulation Number | 878.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-08 |
| Decision Date | 1994-04-15 |