The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Auto Suture Titanium Surgical Staples.
| Device ID | K855047 |
| 510k Number | K855047 |
| Device Name: | AUTO SUTURE TITANIUM SURGICAL STAPLES |
| Classification | Staple, Implantable |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Walter S Henning |
| Correspondent | Walter S Henning UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-17 |
| Decision Date | 1986-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521047379 | K855047 | 000 |
| 20884521047447 | K855047 | 000 |
| 20884521047430 | K855047 | 000 |
| 20884521047423 | K855047 | 000 |
| 20884521047409 | K855047 | 000 |
| 20884521047386 | K855047 | 000 |
| 20884521047362 | K855047 | 000 |
| 20884521047355 | K855047 | 000 |
| 20884521047331 | K855047 | 000 |