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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 K860698
Device Name THE BOOSTER
Applicant
Knapps Corp.
5337 Edgewater Dr.
Newark,  CA  94560
Applicant Contact OLIVER L KNAPPS
Correspondent
Knapps Corp.
5337 Edgewater Dr.
Newark,  CA  94560
Correspondent Contact OLIVER L KNAPPS
Regulation Number876.5020
Classification Product Code
LKY  
Date Received02/25/1986
Decision Date 02/03/1989
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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