510(k) K141956

FIBERGRAFT BG MORSELS by Prosidyan, Inc. — Product Code MQV

K141956 is an FDA 510(k) premarket notification submitted by Prosidyan, Inc. for the device "FIBERGRAFT BG MORSELS". The FDA issued a decision of Substantially Equivalent on August 13, 2014. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Prosidyan, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2014
Date Received
July 18, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type