The following data is part of a premarket notification filed by Automated Medical Products Corp. with the FDA for Deepvison.
| Device ID | K942910 |
| 510k Number | K942910 |
| Device Name: | DEEPVISON |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | AUTOMATED MEDICAL PRODUCTS CORP. 1920 N ST. NORTHWEST SUITE 650 Washington, DC 20036 |
| Contact | Bruce F Mackler |
| Correspondent | Bruce F Mackler AUTOMATED MEDICAL PRODUCTS CORP. 1920 N ST. NORTHWEST SUITE 650 Washington, DC 20036 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-21 |
| Decision Date | 1995-07-21 |