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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Irrigation, Urological
510(k) Number K952583
Device Name AQUISEN
Applicant
AQUINTEL, INC.
2620 STRATFORD LN.
LONGMONT,  CO  80503
Applicant Contact ROBERT K MITCHINER
Correspondent
AQUINTEL, INC.
2620 STRATFORD LN.
LONGMONT,  CO  80503
Correspondent Contact ROBERT K MITCHINER
Regulation Number876.5130
Classification Product Code
LJH  
Date Received06/05/1995
Decision Date 08/24/1995
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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