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FDA 510(k) Application Details - K974173
Device Classification Name
Device, External Penile Rigidity
More FDA Info for this Device
510(K) Number
K974173
Device Name
Device, External Penile Rigidity
Applicant
IMAGYN MEDICAL TECHNOLOGIES, INC.
5 CIVIC PLAZA, SUITE 100
NEWPORT BEACH, CA 92660 US
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Contact
RONALD H BERGESON
Other 510(k) Applications for this Contact
Regulation Number
876.5020
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Classification Product Code
LKY
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More FDA Info for this Product Code
Date Received
11/05/1997
Decision Date
02/25/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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