FDA 510(k) Application Details - K960238

Device Classification Name Wrap, Sterilization

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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
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Regulation Number 880.6850

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Classification Product Code FRG
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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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