The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Valleylab Model E252oh, Force Gsu(tm) Handset.
| Device ID | K926481 |
| 510k Number | K926481 |
| Device Name: | VALLEYLAB MODEL E252OH, FORCE GSU(TM) HANDSET |
| Classification | Electrosurgical, Cutting & Coagulation & 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-29 |
| Decision Date | 1994-02-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884524000862 | K926481 | 000 |
| 20884524000975 | K926481 | 000 |
| 20884524000968 | K926481 | 000 |
| 20884524000852 | K926481 | 000 |
| 20884524000456 | K926481 | 000 |
| 10884521713406 | K926481 | 000 |
| 10884524000978 | K926481 | 000 |