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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, penis, rigid rod
510(k) Number K983015
Device Name VIRILIS PENILE PROSTHESIS
Applicant
SPECIALTY SURGICAL PRODUCTS, INC.
302 NORTH FIRST ST.
HAMILTON,  MT  59840
Applicant Contact T.JAN VARNER
Correspondent
SPECIALTY SURGICAL PRODUCTS, INC.
302 NORTH FIRST ST.
HAMILTON,  MT  59840
Correspondent Contact T.JAN VARNER
Regulation Number876.3630
Classification Product Code
FTQ  
Date Received08/28/1998
Decision Date 02/05/1999
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
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