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FDA 510(k) Application Details - K960238
Device Classification Name
Wrap, Sterilization
More FDA Info for this Device
510(K) Number
K960238
Device Name
Wrap, Sterilization
Applicant
CUSTOM PACK RELIABILITY
4207 VINELAND ROAD, M-1
ORLANDO, FL 32811 US
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Contact
RICHARD L ELLWOOD
Other 510(k) Applications for this Contact
Regulation Number
880.6850
More FDA Info for this Regulation Number
Classification Product Code
FRG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/16/1996
Decision Date
03/28/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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