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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, penile
510(k) Number K864040
Device Name BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS
Applicant
C.R. BARD, INC.
111 SPRING ST.
MURRAY HILL,  NJ  07974
Applicant Contact CATHERINE V BEATH
Correspondent
C.R. BARD, INC.
111 SPRING ST.
MURRAY HILL,  NJ  07974
Correspondent Contact CATHERINE V BEATH
Regulation Number876.3630
Classification Product Code
FAE  
Date Received10/16/1986
Decision Date 10/24/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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