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 Hemostatic Clip.
| Device ID | K853650 |
| 510k Number | K853650 |
| Device Name: | AUTO SUTURE TITANIUM HEMOSTATIC CLIP |
| Classification | Clip, Implantable |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Walter Henning |
| Correspondent | Walter Henning UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-03 |
| Decision Date | 1985-09-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889942313938 | K853650 | 000 |