FDA 510(k) Application Details - K960615

Device Classification Name Gauze/Sponge, Internal

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510(K) Number K960615
Device Name Gauze/Sponge, Internal
Applicant CERTIFIED SAFETY MFG., INC.
1400 CHESTNUT
KANSAS CITY, MO 64127 US
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Contact HOWARD GERSON
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Regulation Number 000.0000

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Classification Product Code EFQ
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Date Received 02/13/1996
Decision Date 11/25/1996
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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