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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 K864833
Device Name POS-T-VAC
Applicant
Ekc, Inc.
312 Grammont St., Suite 401
Monroe,  LA  71201
Applicant Contact WALKER, M.D.
Correspondent
Ekc, Inc.
312 Grammont St., Suite 401
Monroe,  LA  71201
Correspondent Contact WALKER, M.D.
Regulation Number876.5020
Classification Product Code
LKY  
Date Received12/09/1986
Decision Date 04/10/1987
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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