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FDA 510(k) Application Details - K974470
Device Classification Name
Device, External Penile Rigidity
More FDA Info for this Device
510(K) Number
K974470
Device Name
Device, External Penile Rigidity
Applicant
ENCORE, INC.
1900 K ST. , N.W.
WASHINGTON, DC 20005 US
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Contact
DONALD R STONE
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
11/26/1997
Decision Date
01/09/1998
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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