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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, External Penile Rigidity
510(k) Number K990008
Device Name ERCO-RIBBON -C
Applicant
Ercons, Inc.
66 Overlook Ter., Suite 2e
New York,  NY  10040
Applicant Contact YAKOV ALTSHULER
Correspondent
Ercons, Inc.
66 Overlook Ter., Suite 2e
New York,  NY  10040
Correspondent Contact YAKOV ALTSHULER
Regulation Number876.5020
Classification Product Code
LKY  
Date Received01/04/1999
Decision Date 02/24/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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