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FDA 510(k) Application Details - K971257
Device Classification Name
Device, External Penile Rigidity
More FDA Info for this Device
510(K) Number
K971257
Device Name
Device, External Penile Rigidity
Applicant
MCKENNA & CUNEO
1900 K STREET, N.W.
WASHINGTON, DC 20006-1108 US
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Contact
DONALD R STONE
Other 510(k) Applications for this Contact
Regulation Number
876.5020
More FDA Info for this Regulation Number
Classification Product Code
LKY
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More FDA Info for this Product Code
Date Received
04/04/1997
Decision Date
10/03/1997
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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