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FDA 510(k) Application Details - K980461
Device Classification Name
Prosthesis, Chin, Internal
More FDA Info for this Device
510(K) Number
K980461
Device Name
Prosthesis, Chin, Internal
Applicant
SPECTRUM DESIGNS, INC.
5921 C. MATTHEWS ST.
GOLETA, CA 93117 US
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Contact
JIM DISHMAN
Other 510(k) Applications for this Contact
Regulation Number
878.3550
More FDA Info for this Regulation Number
Classification Product Code
FWP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/05/1998
Decision Date
03/04/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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