510(k) K130282

REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT by Remington Medical, Inc. — Product Code KNW

K130282 is an FDA 510(k) premarket notification submitted by Remington Medical, Inc. for the device "REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT". The FDA issued a decision of Substantially Equivalent on May 13, 2013. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Remington Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2013
Date Received
February 5, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type