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FDA 510(k) Application Details - K983438
Device Classification Name
Device, External Penile Rigidity
More FDA Info for this Device
510(K) Number
K983438
Device Name
Device, External Penile Rigidity
Applicant
DOREA, INC.
19 4TH AVENUE, S.E.
CAIRO, GA 31728 US
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Contact
RICHARD V MOSES,JR.
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
09/29/1998
Decision Date
02/08/1999
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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