The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Force Gsu System Model No. Gsu-20 And Gsu-22.
Device ID | K942579 |
510k Number | K942579 |
Device Name: | FORCE GSU SYSTEM MODEL NO. GSU-20 AND GSU-22 |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder, CO 80301 |
Contact | Charles M Copperberg |
Correspondent | Charles M Copperberg VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder, CO 80301 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-31 |
Decision Date | 1994-09-21 |