The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Disp. Loading Unit, Auto, Suture.
| Device ID | K771178 |
| 510k Number | K771178 |
| Device Name: | DISP. LOADING UNIT, AUTO, SUTURE |
| Classification | Staple, Implantable |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-06-30 |
| Decision Date | 1977-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884523006565 | K771178 | 000 |
| 20884523006558 | K771178 | 000 |
| 20884523006541 | K771178 | 000 |