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FDA 510(k) Application Details - K971076
Device Classification Name
Cover, Shoe, Operating-Room
More FDA Info for this Device
510(K) Number
K971076
Device Name
Cover, Shoe, Operating-Room
Applicant
PRIMELINE MEDICAL PRODUCTS, INC.
2235-27TH AVENUE, N.E.
CALGARY
ALBERTA T2E 7M4 CA
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Contact
GUY PLAMONDON
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Regulation Number
878.4040
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Classification Product Code
FXP
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More FDA Info for this Product Code
Date Received
03/24/1997
Decision Date
01/13/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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