The following data is part of a premarket notification filed by Pfm Medical, Inc with the FDA for Safety Biopsy Needle System.
| Device ID | K140137 |
| 510k Number | K140137 |
| Device Name: | SAFETY BIOPSY NEEDLE SYSTEM |
| Classification | Biopsy Needle |
| Applicant | PFM MEDICAL, INC 1815 ASTON AVE, SUITE 106 Carlsbad, CA 92008 |
| Contact | Salvadore Palomares |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-01-22 |
| Decision Date | 2014-03-25 |
| Summary: | summary |