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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
Other 510(k) Applications for this Contact
Regulation Number
878.4450
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Classification Product Code
GDY
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More FDA Info for this Product Code
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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