FDA 510(k) Application Details - K960216

Device Classification Name Catheter And Tip, Suction

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510(K) Number K960216
Device Name Catheter And Tip, Suction
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 880.6740

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Classification Product Code JOL
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Date Received 01/16/1996
Decision Date 04/15/1996
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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