FDA 510(k) Application Details - K990567

Device Classification Name Wrap, Sterilization

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510(K) Number K990567
Device Name Wrap, Sterilization
Applicant GLOBAL HEALTHCARE, INC.
130 BRANTLEY RD.
ATLANTA, GA 30350 US
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Contact ALAM AHMED
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Regulation Number 880.6850

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Classification Product Code FRG
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Date Received 02/23/1999
Decision Date 04/05/1999
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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