Device Classification Name |
Fastener, Fixation, Biodegradable, Soft Tissue
More FDA Info for this Device |
510(K) Number |
K960555 |
Device Name |
Fastener, Fixation, Biodegradable, Soft Tissue |
Applicant |
INSTRUMENT MAKAR, INC.
C/O ABOOD,ABOOD & RHEAUME,P.C.
117 EAST ALLEGAN STREET
LANSING, MI 48933 US
Other 510(k) Applications for this Company
|
Contact |
ANDREW P ABOOD
Other 510(k) Applications for this Contact |
Regulation Number |
888.3030
More FDA Info for this Regulation Number |
Classification Product Code |
MAI
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
02/09/1996 |
Decision Date |
07/09/1996 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
OR - Orthopedic |
Review Advisory Committee |
OR - Orthopedic |
Statement / Summary / Purged Status |
Statement |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|