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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 K932397
Device Name RELIANT
Applicant
Allan Walling Medical Equipment Co.
12890 Hillcrest Rd.,
Suite 201
Dallas,  TX  75230
Applicant Contact ALLAN WALLING
Correspondent
Allan Walling Medical Equipment Co.
12890 Hillcrest Rd.,
Suite 201
Dallas,  TX  75230
Correspondent Contact ALLAN WALLING
Regulation Number876.5020
Classification Product Code
LKY  
Date Received05/18/1993
Decision Date 03/07/1994
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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