The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Valleylab Procision(tm) System.
| Device ID | K945688 |
| 510k Number | K945688 |
| Device Name: | VALLEYLAB PROCISION(TM) SYSTEM |
| 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 | 1994-11-21 |
| Decision Date | 1995-06-13 |