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FDA 510(k) Application Details - K051625
Device Classification Name
Drape, Surgical
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510(K) Number
K051625
Device Name
Drape, Surgical
Applicant
MOLNLYCKE HEALTH CARE, INC.
826 NEWTOWN-YARDLEY RD.
NEWTOWN, PA 18940 US
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Contact
JOHN CLAY
Other 510(k) Applications for this Contact
Regulation Number
878.4370
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Classification Product Code
KKX
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More FDA Info for this Product Code
Date Received
06/20/2005
Decision Date
07/14/2005
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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