FDA 510(k) Application Details - K993871

Device Classification Name Wrap, Sterilization

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510(K) Number K993871
Device Name Wrap, Sterilization
Applicant ALLEGIANCE HEALTHCARE CORP.
1500 WAUKEGAN RD.- K
MCGRAW PARK, IL 60085 US
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Contact PATRICIA SHARPE-GREGG
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Regulation Number 880.6850

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Classification Product Code FRG
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Date Received 11/15/1999
Decision Date 04/21/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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