The following data is part of a premarket notification filed by M.p. Video, Inc. with the FDA for Autoclaveable Medicam 900 Digicon Camera.
| Device ID | K942358 |
| 510k Number | K942358 |
| Device Name: | AUTOCLAVEABLE MEDICAM 900 DIGICON CAMERA |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | M.P. VIDEO, INC. 4 MARC RD. Medway, MA 02053 |
| Contact | Winifred Shannon |
| Correspondent | Winifred Shannon M.P. VIDEO, INC. 4 MARC RD. Medway, MA 02053 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-17 |
| Decision Date | 1994-08-08 |