The following data is part of a premarket notification filed by Surgical Technologies, Inc. with the FDA for Sti Tissue Manipulator.
Device ID | K911699 |
510k Number | K911699 |
Device Name: | STI TISSUE MANIPULATOR |
Classification | Coagulator-cutter, Endoscopic, Bipolar (and Accessories) |
Applicant | SURGICAL TECHNOLOGIES, INC. 750 GODDARD AVE. Chesterfield, MO 63005 |
Contact | Alan T Beckman |
Correspondent | Alan T Beckman SURGICAL TECHNOLOGIES, INC. 750 GODDARD AVE. Chesterfield, MO 63005 |
Product Code | HIN |
CFR Regulation Number | 884.4150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-16 |
Decision Date | 1991-06-13 |