The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Valleylab Ns 2000 Bipolar Generator System.
| Device ID | K946177 |
| 510k Number | K946177 |
| Device Name: | VALLEYLAB NS 2000 BIPOLAR GENERATOR SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder, CO 80301 |
| Contact | Julie Ross |
| Correspondent | Julie Ross 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 | 1994-12-19 |
| Decision Date | 1995-06-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884524001661 | K946177 | 000 |