The following data is part of a premarket notification filed by M.p. Video, Inc. with the FDA for Combination Camera/light Source.
| Device ID | K951386 |
| 510k Number | K951386 |
| Device Name: | COMBINATION CAMERA/LIGHT SOURCE |
| 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 |
| Subsequent Product Code | FST |
| Subsequent Product Code | FSW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-27 |
| Decision Date | 1995-06-30 |