The following data is part of a premarket notification filed by Allen Medical Systems, Inc. with the FDA for Carbon Lights Hand Surgery Table.
| Device ID | K944779 |
| 510k Number | K944779 |
| Device Name: | CARBON LIGHTS HAND SURGERY TABLE |
| Classification | Operating Room Accessories Table Tray |
| Applicant | ALLEN MEDICAL SYSTEMS, INC. 5198 RICHMOND RD. Bedford Heights, OH 44146 |
| Contact | Suzanne K Ratzloff |
| Correspondent | Suzanne K Ratzloff ALLEN MEDICAL SYSTEMS, INC. 5198 RICHMOND RD. Bedford Heights, OH 44146 |
| Product Code | FWZ |
| CFR Regulation Number | 878.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-27 |
| Decision Date | 1994-10-14 |