The following data is part of a premarket notification filed by United Surgical Corp. with the FDA for Parametric Sterility Release Of Auto.
| Device ID | K830741 |
| 510k Number | K830741 |
| Device Name: | PARAMETRIC STERILITY RELEASE OF AUTO |
| Classification | Stapler, Surgical |
| Applicant | UNITED SURGICAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GAG |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-08 |
| Decision Date | 1983-08-11 |