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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 K834347
Device Name FLEXI-FLATE PENILE IMPLANT
Applicant
Surgitek
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Surgitek
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.3630
Classification Product Code
FAE  
Date Received12/13/1983
Decision Date 04/02/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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