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FDA 510(k) Application Details - K023025
Device Classification Name
Wrap, Sterilization
More FDA Info for this Device
510(K) Number
K023025
Device Name
Wrap, Sterilization
Applicant
GRANTON MEDICAL LTD.
PO BOX 4341
CROFTON, MD 21114 US
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Contact
E. J. SMITH
Other 510(k) Applications for this Contact
Regulation Number
880.6850
More FDA Info for this Regulation Number
Classification Product Code
FRG
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More FDA Info for this Product Code
Date Received
09/11/2002
Decision Date
03/04/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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