FDA 510(k) Applications for Medical Device:
Prosthesis, Penile

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K963328 AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST
MINNETONKA MN 55343
K082006 AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST
MINNETONKA MN 55343
K090663 AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST
MINNETONKA MN 55343
K183619 Boston Scientific Corporation 10700 Bren Road West
Minnetonka MN 55343
K040959 MENTOR CORP. 201 MENTOR DR.
SANTA BARBARA CA 93111
K181673 Rigicon Inc. 150 Motor Pkwy S401
Hauppauge NY 11788




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