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 |