510(k) K060987

OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 by Cp Medical — Product Code MTJ

K060987 is an FDA 510(k) premarket notification submitted by Cp Medical for the device "OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31". The FDA issued a decision of Substantially Equivalent on November 2, 2006. The device falls under product code MTJ (Wax, Bone), a Class U device. Cp Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2006
Date Received
April 10, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wax, Bone
Device Class
Class U
Regulation Number
Review Panel
OR
Submission Type