The following data is part of a premarket notification filed by Envision Medical Corp. with the FDA for Camera, Surgical And Accessories.
| Device ID | K934092 |
| 510k Number | K934092 |
| Device Name: | CAMERA, SURGICAL AND ACCESSORIES |
| Classification | Camera, Television, Surgical, Without Audio |
| Applicant | ENVISION MEDICAL CORP. 7220 HOLLISTER AVE. Goleta, CA 93117 |
| Contact | Daniel P Mcguire |
| Correspondent | Daniel P Mcguire ENVISION MEDICAL CORP. 7220 HOLLISTER AVE. Goleta, CA 93117 |
| Product Code | FWB |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-23 |
| Decision Date | 1994-01-07 |