The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Force Argon Ii Argon Enhanced Electrosurgical System.
| Device ID | K964636 |
| 510k Number | K964636 |
| Device Name: | FORCE ARGON II ARGON ENHANCED ELECTROSURGICAL 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 | 1996-11-19 |
| Decision Date | 1997-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884524002149 | K964636 | 000 |
| 10884524003078 | K964636 | 000 |
| 10884524002569 | K964636 | 000 |
| 10884524002552 | K964636 | 000 |
| 10884521104211 | K964636 | 000 |