The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Modified Versaport.
| Device ID | K954108 |
| 510k Number | K954108 |
| Device Name: | MODIFIED VERSAPORT |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Victor Clavelli |
| Correspondent | Victor Clavelli UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-03 |
| Decision Date | 1995-10-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521082670 | K954108 | 000 |
| 10884521082663 | K954108 | 000 |
| 10884521082656 | K954108 | 000 |
| 10884521082649 | K954108 | 000 |
| 10884521081154 | K954108 | 000 |
| 10884521094444 | K954108 | 000 |
| 10884521094420 | K954108 | 000 |
| 10884521094314 | K954108 | 000 |