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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K912093
Device Name DISPOSABLE ASPIRATION IRRIGATION SYSTEM
Applicant
Applied Urology, Inc.
26051 Merit Cir.
Bldg. 104
Launa Hills,  CA  92653
Applicant Contact JO STEGWELL
Correspondent
Applied Urology, Inc.
26051 Merit Cir.
Bldg. 104
Launa Hills,  CA  92653
Correspondent Contact JO STEGWELL
Regulation Number884.1720
Classification Product Code
HET  
Date Received05/14/1991
Decision Date 04/24/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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