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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 K974215
Device Name VET-CO OTC VACUUM DEVICE/VET-CO CONSTRICTION RING SET
Applicant
Vetco, Inc.
3700 5th Ave. S.
Birmingham,  AL  35222
Applicant Contact JEFF SHAPIRO
Correspondent
Vetco, Inc.
3700 5th Ave. S.
Birmingham,  AL  35222
Correspondent Contact JEFF SHAPIRO
Regulation Number876.5020
Classification Product Code
LKY  
Date Received11/10/1997
Decision Date 02/19/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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