FDA 510(k) Application Details - K001189

Device Classification Name Gown, Surgical

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510(K) Number K001189
Device Name Gown, 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 878.4040

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Classification Product Code FYA
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Date Received 04/12/2000
Decision Date 04/21/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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