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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 K921335
Device Name ULTRAFLOW SUCTION-IRRIGATION CANNULA
Applicant
Endoscopic Surgical Products, Inc.
5571 Bristol Ln.
Minnetonka,  MN  55343
Applicant Contact JOSEPH PIETRAITTA
Correspondent
Endoscopic Surgical Products, Inc.
5571 Bristol Ln.
Minnetonka,  MN  55343
Correspondent Contact JOSEPH PIETRAITTA
Regulation Number884.1720
Classification Product Code
HET  
Date Received03/18/1992
Decision Date 02/03/1994
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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