The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Autosuture Circular Eea Surgical Staplers.
| Device ID | K062850 |
| 510k Number | K062850 |
| Device Name: | AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS |
| Classification | Staple, Implantable |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Frank Gianelli |
| Correspondent | Frank Gianelli 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-25 |
| Decision Date | 2006-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521042865 | K062850 | 000 |
| 10884523004731 | K062850 | 000 |
| 20884523005551 | K062850 | 000 |
| 20884523005568 | K062850 | 000 |
| 20884523005575 | K062850 | 000 |
| 20884523005582 | K062850 | 000 |
| 20884523006053 | K062850 | 000 |
| 20884523006121 | K062850 | 000 |
| 20884523006138 | K062850 | 000 |
| 20884523006145 | K062850 | 000 |
| 20884523006169 | K062850 | 000 |
| 20884523006176 | K062850 | 000 |
| 10884523004663 | K062850 | 000 |
| 10884523004724 | K062850 | 000 |
| 10884523004748 | K062850 | 000 |
| 10884523005530 | K062850 | 000 |
| 10884523005547 | K062850 | 000 |
| 20884521042848 | K062850 | 000 |