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FDA 510(k) Application Details - K072456
Device Classification Name
More FDA Info for this Device
510(K) Number
K072456
Device Name
DESARA MESH SLING, MODEL CAL-DS01
Applicant
CALDERA MEDICAL, INC.
1205 DE LA VINA
SANTA BARBARA, CA 93101 US
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Contact
CHRISTINE EMANUEL
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
OTN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/31/2007
Decision Date
05/08/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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