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FDA 510(k) Application Details - K000906
Device Classification Name
Drape, Surgical
More FDA Info for this Device
510(K) Number
K000906
Device Name
Drape, Surgical
Applicant
MOLNLYCKE HEALTH CARE, INC.
500 BALDWIN TOWER
EDDYSTONE, PA 19022 US
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Contact
MIGUEL A NEGRON
Other 510(k) Applications for this Contact
Regulation Number
878.4370
More FDA Info for this Regulation Number
Classification Product Code
KKX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/21/2000
Decision Date
06/23/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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