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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 K020969
Device Name VACURECT VACUUM CONSTRICTION DEVICE
Applicant
VACURECT MANUFACTURING (PTY) LTD.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact MARY MCNAMARA-CULLINANE
Correspondent
VACURECT MANUFACTURING (PTY) LTD.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact MARY MCNAMARA-CULLINANE
Regulation Number876.5020
Classification Product Code
LKY  
Date Received03/26/2002
Decision Date 06/05/2002
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
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