The following data is part of a premarket notification filed by Bioform Medical, Inc. with the FDA for Modification To Gfx Nerve Ablation System.
| Device ID | K081729 |
| 510k Number | K081729 |
| Device Name: | MODIFICATION TO GFX NERVE ABLATION SYSTEM |
| Classification | Generator, Lesion, Radiofrequency |
| Applicant | BIOFORM MEDICAL, INC. 4133 COURTNEY ROAD, #10 Franksville, WI 53126 |
| Contact | Lori Hays |
| Correspondent | Lori Hays BIOFORM MEDICAL, INC. 4133 COURTNEY ROAD, #10 Franksville, WI 53126 |
| Product Code | GXD |
| CFR Regulation Number | 882.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-18 |
| Decision Date | 2008-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B653RFG100TC0 | K081729 | 000 |
| B653PB100T0 | K081729 | 000 |