The following data is part of a premarket notification filed by General Medical Co. with the FDA for C.a.s.e. Container.
| Device ID | K844652 |
| 510k Number | K844652 |
| Device Name: | C.A.S.E. CONTAINER |
| Classification | Tray, Surgical, Instrument |
| Applicant | GENERAL MEDICAL CO. 1575 EYE ST. NW Washington, DC 20005 |
| Contact | Daniel J Manelli |
| Correspondent | Daniel J Manelli GENERAL MEDICAL CO. 1575 EYE ST. NW Washington, DC 20005 |
| Product Code | FSM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-29 |
| Decision Date | 1984-12-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885403426292 | K844652 | 000 |
| 10885403037160 | K844652 | 000 |
| 10885403037177 | K844652 | 000 |
| 10885403037191 | K844652 | 000 |
| 10885403037207 | K844652 | 000 |
| 10885403037214 | K844652 | 000 |
| 10885403037221 | K844652 | 000 |
| 10885403037245 | K844652 | 000 |
| 10885403037269 | K844652 | 000 |
| 10885403037283 | K844652 | 000 |
| 10885403037382 | K844652 | 000 |
| 10885403037429 | K844652 | 000 |
| 10885403426285 | K844652 | 000 |
| 10885403017933 | K844652 | 000 |