FDA 510(k) Application Details - K964125

Device Classification Name Drape, Surgical

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510(K) Number K964125
Device Name Drape, Surgical
Applicant ALLEGIANCE HEALTHCARE CORP.
1500 WAUKEGAN RD.- K
MCGRAW PARK, IL 60085 US
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Contact SHARON ROBBINS
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Regulation Number 878.4370

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Classification Product Code KKX
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Date Received 10/15/1996
Decision Date 12/23/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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