The following data is part of a premarket notification filed by Edgewater Medical Equipment Systems with the FDA for Allen Malleable Anesthesia Screen.
| Device ID | K873370 |
| 510k Number | K873370 |
| Device Name: | ALLEN MALLEABLE ANESTHESIA SCREEN |
| Classification | Operating Room Accessories Table Tray |
| Applicant | EDGEWATER MEDICAL EQUIPMENT SYSTEMS 6263 MAYFIELD RD. SUITE 206 Mayfield Hts., OH 44124 |
| Contact | Daniel Allen |
| Correspondent | Daniel Allen EDGEWATER MEDICAL EQUIPMENT SYSTEMS 6263 MAYFIELD RD. SUITE 206 Mayfield Hts., OH 44124 |
| Product Code | FWZ |
| CFR Regulation Number | 878.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-21 |
| Decision Date | 1987-09-11 |