The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Force 1c.
Device ID | K921222 |
510k Number | K921222 |
Device Name: | FORCE 1C |
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 | 1992-03-13 |
Decision Date | 1992-09-23 |