The following data is part of a premarket notification filed by Influence, Inc. with the FDA for Urotac Bone Anchor Inserter.
Device ID | K962372 |
510k Number | K962372 |
Device Name: | UROTAC BONE ANCHOR INSERTER |
Classification | Staple Driver |
Applicant | INFLUENCE, INC. 637 STEINER ST. San Francisco, CA 94117 |
Contact | Peter A Bick |
Correspondent | Peter A Bick INFLUENCE, INC. 637 STEINER ST. San Francisco, CA 94117 |
Product Code | HXJ |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-19 |
Decision Date | 1996-08-19 |
Summary: | summary |