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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 K941087
Device Name POS-T-VAC-AVP-1000
Applicant
Pos-T-Vac, Inc.
1701 N. 14th Ave.
P.O. Box 1436
Dodge City,  KS  67801
Applicant Contact EDWARD T STEWART, SR.
Correspondent
Pos-T-Vac, Inc.
1701 N. 14th Ave.
P.O. Box 1436
Dodge City,  KS  67801
Correspondent Contact EDWARD T STEWART, SR.
Regulation Number876.5020
Classification Product Code
LKY  
Date Received03/08/1994
Decision Date 07/25/1994
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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