The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Surgistat.
Device ID | K922206 |
510k Number | K922206 |
Device Name: | SURGISTAT |
Classification | Electrocautery, Gynecologic (and Accessories) |
Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
Contact | Peggy Walline |
Correspondent | Peggy Walline VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
Product Code | HGI |
CFR Regulation Number | 884.4120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-12 |
Decision Date | 1993-09-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SURGISTAT 85370470 not registered Dead/Abandoned |
Hemostasis, LLC 2011-07-13 |
SURGISTAT 73297226 1198551 Live/Registered |
Valleylab, Inc. 1981-02-17 |