The following data is part of a premarket notification filed by Remington Medical, Inc. with the FDA for Remington Medical Centrefire 22 Biopsy Instrument.
| Device ID | K130282 |
| 510k Number | K130282 |
| Device Name: | REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT |
| Classification | Instrument, Biopsy |
| Applicant | REMINGTON MEDICAL, INC. 6830 MEADOWRIDGE CT. Alpharetta, GA 30005 |
| Contact | Caitlin Senter, Ms, Rac |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-02-05 |
| Decision Date | 2013-05-13 |
| Summary: | summary |