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FDA 510(k) Application Details - K040707
Device Classification Name
Wrap, Sterilization
More FDA Info for this Device
510(K) Number
K040707
Device Name
Wrap, Sterilization
Applicant
VYGON US LLC
2495 GENERAL ARMSTEAD AVE.
NORRISTOWN, PA 19403 US
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Contact
COURTNEY SMITH
Other 510(k) Applications for this Contact
Regulation Number
880.6850
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Classification Product Code
FRG
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More FDA Info for this Product Code
Date Received
03/18/2004
Decision Date
04/16/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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