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 Abbi System.
| Device ID | K983296 |
| 510k Number | K983296 |
| Device Name: | AUTO SUTURE ABBI SYSTEM |
| Classification | Instrument, Biopsy |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Christopher A Graham |
| Correspondent | Christopher A Graham UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-21 |
| Decision Date | 1999-06-04 |
| Summary: | summary |