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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 K993142
Device Name ELITE CUSTOM
Applicant
SOMA BLUE, INC.
P.O. BOX 1447
1025 BROAD STREET
AUGUSTA,  GA  30903
Applicant Contact JOHN M MITCHELL
Correspondent
SOMA BLUE, INC.
P.O. BOX 1447
1025 BROAD STREET
AUGUSTA,  GA  30903
Correspondent Contact JOHN M MITCHELL
Regulation Number876.5020
Classification Product Code
LKY  
Date Received09/21/1999
Decision Date 12/27/1999
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
Predetermined Change
Control Plan Authorized		 No
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