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FDA 510(k) Application Details - K070078
Device Classification Name
Gown, Surgical
More FDA Info for this Device
510(K) Number
K070078
Device Name
Gown, Surgical
Applicant
STRYKER INSTRUMENTS, INSTRUMENTS DIV.
4100 EAST MILHAM AVE.
KALAMAZOO, MI 49001 US
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Contact
PAULETTE D JOHNSON
Other 510(k) Applications for this Contact
Regulation Number
878.4040
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Classification Product Code
FYA
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More FDA Info for this Product Code
Date Received
01/09/2007
Decision Date
02/02/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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