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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K933353
Device Name IRRIGATION AND ASPIRATION DEVICE FOR LAPAROSCOPIC AND OPEN SURGICAL PROCEDURES
Applicant
Utah Pioneer Medical, Inc.
6556 W. 3820 S.
West Valley City,  UT  84120
Applicant Contact WILLIAM J WALLIS
Correspondent
Utah Pioneer Medical, Inc.
6556 W. 3820 S.
West Valley City,  UT  84120
Correspondent Contact WILLIAM J WALLIS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/09/1993
Decision Date 02/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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