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FDA 510(k) Application Details - K020082
Device Classification Name
Device, External Penile Rigidity
More FDA Info for this Device
510(K) Number
K020082
Device Name
Device, External Penile Rigidity
Applicant
ENDOCARE, INC.
6585 CITY WEST PKWY.
EDEN PRAIRIE, MN 55344 US
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Contact
CHRIS HADLAND
Other 510(k) Applications for this Contact
Regulation Number
876.5020
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Classification Product Code
LKY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/10/2002
Decision Date
02/05/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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