The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Valleylab Force Gsu Handset Adapter Model #e0500.
| Device ID | K933181 |
| 510k Number | K933181 |
| Device Name: | VALLEYLAB FORCE GSU HANDSET ADAPTER MODEL #E0500 |
| Classification | Osteotome, Manual |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Charles Copperberg |
| Correspondent | Charles Copperberg VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
| Product Code | GFI |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-30 |
| Decision Date | 1993-11-02 |