The following data is part of a premarket notification filed by Valleylab with the FDA for Valleylab Forcetriad Electrosurgical Generator.
Device ID | K051644 |
510k Number | K051644 |
Device Name: | VALLEYLAB FORCETRIAD ELECTROSURGICAL GENERATOR |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | VALLEYLAB 5920 LONGBOW DR. Boulder, CO 80301 |
Contact | Herbert Vinson |
Correspondent | Herbert Vinson VALLEYLAB 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 | 2005-06-20 |
Decision Date | 2005-08-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10884524001678 | K051644 | 000 |
10884524002545 | K051644 | 000 |