The following data is part of a premarket notification filed by Edgewater Medical Systems, Inc. with the FDA for Allen Lateral Armboard.
| Device ID | K881292 |
| 510k Number | K881292 |
| Device Name: | ALLEN LATERAL ARMBOARD |
| Classification | Board, Arm (with Cover), Sterile |
| Applicant | EDGEWATER MEDICAL SYSTEMS, INC. 6263 MAYFIELD RD #206 Mayfield Hts., OH 44124 |
| Contact | Daniel Allen |
| Correspondent | Daniel Allen EDGEWATER MEDICAL SYSTEMS, INC. 6263 MAYFIELD RD #206 Mayfield Hts., OH 44124 |
| Product Code | BTX |
| CFR Regulation Number | 878.3910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-28 |
| Decision Date | 1988-04-07 |