The following data is part of a premarket notification filed by Envision Medical Corp. with the FDA for Surgical Integrated Camera System.
| Device ID | K953438 |
| 510k Number | K953438 |
| Device Name: | SURGICAL INTEGRATED CAMERA SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ENVISION MEDICAL CORP. 749 WARD DR. Santa Barbara, CA 93111 |
| Contact | Daniel P Mcguire |
| Correspondent | Daniel P Mcguire ENVISION MEDICAL CORP. 749 WARD DR. Santa Barbara, CA 93111 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-21 |
| Decision Date | 1995-11-06 |