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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 K971768
Device Name RELIANT CHARGER
Applicant
WALLING MEDICAL EQUIPMENT CO.
3000 CANDIDE LN.
MCKINNEY,  TX  75070
Applicant Contact ALLAN WALLING
Correspondent
WALLING MEDICAL EQUIPMENT CO.
3000 CANDIDE LN.
MCKINNEY,  TX  75070
Correspondent Contact ALLAN WALLING
Regulation Number876.5020
Classification Product Code
LKY  
Date Received05/13/1997
Decision Date 09/29/1997
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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