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FDA 510(k) Application Details - K964011
Device Classification Name
General Surgery Tray
More FDA Info for this Device
510(K) Number
K964011
Device Name
General Surgery Tray
Applicant
CUSTOMED, INC.
CALLE IGUALDAD #7
FAJARDO, PR 00738 US
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Contact
OSVALDO RODRIGUEZ
Other 510(k) Applications for this Contact
Regulation Number
878.4370
More FDA Info for this Regulation Number
Classification Product Code
LRO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/07/1996
Decision Date
11/25/1996
Decision
SESK - SUBST EQUIV - KIT
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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