The following data is part of a premarket notification filed by Vista Medical Technologies, Inc. with the FDA for Vista Orpc With Infomatix Intraop Software.
| Device ID | K991303 |
| 510k Number | K991303 |
| Device Name: | VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | VISTA MEDICAL TECHNOLOGIES, INC. 134 FLANDERS RD. Westborough, MA 01581 |
| Contact | Vicki Anastasi |
| Correspondent | Vicki Anastasi VISTA MEDICAL TECHNOLOGIES, INC. 134 FLANDERS RD. Westborough, MA 01581 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-16 |
| Decision Date | 1999-07-12 |
| Summary: | summary |