The following data is part of a premarket notification filed by Path Scientific, Llc with the FDA for Pathformer.
| Device ID | K052770 |
| 510k Number | K052770 |
| Device Name: | PATHFORMER |
| Classification | Drill, Battery Powered, Subungual Hematoma |
| Applicant | PATH SCIENTIFIC, LLC 5600 WISCONSIN AVE, #509 Chevy Chase, MD 20815 |
| Contact | Patsy J Trisler |
| Correspondent | Patsy J Trisler PATH SCIENTIFIC, LLC 5600 WISCONSIN AVE, #509 Chevy Chase, MD 20815 |
| Product Code | NWF |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-30 |
| Decision Date | 2005-10-31 |
| Summary: | summary |