The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Valleylab Force Fx.
| Device ID | K944602 |
| 510k Number | K944602 |
| Device Name: | VALLEYLAB FORCE FX |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Charles M Copperberg |
| Correspondent | Charles M Copperberg VALLEYLAB, INC. 5920 LONGBOW DR. 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 | 1994-09-19 |
| Decision Date | 1995-06-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521133945 | K944602 | 000 |
| 10884521780576 | K944602 | 000 |
| 10884524001562 | K944602 | 000 |
| 10884524002590 | K944602 | 000 |
| 10884524002620 | K944602 | 000 |
| 10884521512085 | K944602 | 000 |
| 10884524002613 | K944602 | 000 |
| 10884524002651 | K944602 | 000 |
| 10884524002637 | K944602 | 000 |
| 10884521133921 | K944602 | 000 |
| 10884521780569 | K944602 | 000 |