FDA 510(k) Application Details - K991215

Device Classification Name Gauze/Sponge, Internal

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510(K) Number K991215
Device Name Gauze/Sponge, Internal
Applicant SYMTEX HEALTHCARE CORP.
783 PINEFALLS AVE.
WALNUT, CA 91789 US
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Contact RICHARD S WANG
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Regulation Number 000.0000

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Classification Product Code EFQ
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Date Received 04/09/1999
Decision Date 06/11/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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