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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 K960828
Device Name POS-T-VAC B-10 BAND KIT
Applicant
Pos-T-Vac, Inc.
2550 M St. NW
Washington,  DC  20037
Applicant Contact MARK A HELLER
Correspondent
Pos-T-Vac, Inc.
2550 M St. NW
Washington,  DC  20037
Correspondent Contact MARK A HELLER
Regulation Number876.5020
Classification Product Code
LKY  
Date Received02/29/1996
Decision Date 03/08/1996
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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