The following data is part of a premarket notification filed by Envision Medical Corp. with the FDA for 3-ccd Digital Camera.
| Device ID | K970605 |
| 510k Number | K970605 |
| Device Name: | 3-CCD DIGITAL CAMERA |
| 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 | 1997-02-18 |
| Decision Date | 1997-05-22 |
| Summary: | summary |