FDA 510(k) Application Details - K955599

Device Classification Name Gauze/Sponge, Internal, X-Ray Detectable

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510(K) Number K955599
Device Name Gauze/Sponge, Internal, X-Ray Detectable
Applicant STRYKER CORP.
2725 FAIRFIELD RD.
P.O. BOX 4085
KALAMAZOO, MI 49003-4085 US
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Contact TAMMY LOUNDS
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Regulation Number 878.4450

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Classification Product Code GDY
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Date Received 12/08/1995
Decision Date 02/22/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
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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