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FDA 510(k) Application Details - K964827
Device Classification Name
Kit, Suture Removal
More FDA Info for this Device
510(K) Number
K964827
Device Name
Kit, Suture Removal
Applicant
CONTINENTAL MEDICAL LABORATORIES, INC.
817 WEST MOHR AVE.
P.O. BOX 306
WATERFORD, WI 53185 US
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Contact
JOSEPH DUNN
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Regulation Number
000.0000
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Classification Product Code
MCZ
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More FDA Info for this Product Code
Date Received
12/02/1996
Decision Date
02/14/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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