The following data is part of a premarket notification filed by Allen Medical Systems, Inc. with the FDA for Dura-board Armboard.
| Device ID | K964273 |
| 510k Number | K964273 |
| Device Name: | DURA-BOARD ARMBOARD |
| Classification | Table, Operating-room, Electrical |
| Applicant | ALLEN MEDICAL SYSTEMS, INC. 15627 NEO PKWY. Cleveland, OH 44128 |
| Contact | Suzanne K Ratzloff |
| Correspondent | Suzanne K Ratzloff ALLEN MEDICAL SYSTEMS, INC. 15627 NEO PKWY. Cleveland, OH 44128 |
| Product Code | GDC |
| Subsequent Product Code | FQO |
| Subsequent Product Code | FWW |
| CFR Regulation Number | 878.4960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-28 |
| Decision Date | 1997-01-08 |