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FDA 510(k) Application Details - K972537
Device Classification Name
Device, External Penile Rigidity
More FDA Info for this Device
510(K) Number
K972537
Device Name
Device, External Penile Rigidity
Applicant
ERCONS, INC.
66 OVERLOOK TERRACE, SUITE 2E
NEW YORK, NY 10040 US
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Contact
YAKOV ALTSHULER
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
07/08/1997
Decision Date
11/03/1997
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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