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 Gas Powered Disp. Lds Stapl.
| Device ID | K810188 |
| 510k Number | K810188 |
| Device Name: | AUTO SUTURE GAS POWERED DISP. LDS STAPL |
| Classification | Saw, Nasal |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KBC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-22 |
| Decision Date | 1981-03-20 |