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FDA 510(k) Application Details - K061676
Device Classification Name
Monitor, Penile Tumescence
More FDA Info for this Device
510(K) Number
K061676
Device Name
Monitor, Penile Tumescence
Applicant
UROAN 21
12 ANSELM TURMEDA
PALMA DE MALLORCA 07003 ES
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Contact
ANABEL ROSSELLO
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LIL
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More FDA Info for this Product Code
Date Received
06/14/2006
Decision Date
12/27/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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