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FDA 510(k) Application Details - K052528
Device Classification Name
Wax,Bone
More FDA Info for this Device
510(K) Number
K052528
Device Name
Wax,Bone
Applicant
CEREMED, INC.
3643 LENAWEE AVE.
LOS ANGELES, CA 90016 US
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Contact
TADEUSZ WELLISZ
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MTJ
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More FDA Info for this Product Code
Date Received
09/14/2005
Decision Date
10/11/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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