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FDA 510(k) Application Details - K070432
Device Classification Name
Drape, Surgical
More FDA Info for this Device
510(K) Number
K070432
Device Name
Drape, Surgical
Applicant
WELMED INC.
1340 WEST PENNSYLVANIA AVENUE
SAN DIEGO, CA 92103 US
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Contact
Glen Feye
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
02/13/2007
Decision Date
09/24/2007
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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