The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Modified Surgiport Disposable Trocar And Sleeve.
| Device ID | K903419 |
| 510k Number | K903419 |
| Device Name: | MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE |
| Classification | Gouge, Surgical, General & Plastic Surgery |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Steve Reitzler |
| Correspondent | Steve Reitzler UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | GDH |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-31 |
| Decision Date | 1990-08-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521081161 | K903419 | 000 |
| 10884521081130 | K903419 | 000 |