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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 K830667
Device Name SILICONE-SILVER PENILE PROSTHESIS-ESK
Applicant
DACOMED CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
DACOMED CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.3630
Classification Product Code
FTQ  
Date Received03/04/1983
Decision Date 10/20/1983
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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