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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 K915298
Device Name SUCTION/IRRIGATION CANNULA; CATLOG #532.00
Applicant
Lifeguard Medical Products, Inc.
400 Lathrop Ave.
Suite 200
River Forest,  IL  60305
Applicant Contact DOUGLAS HULFISH
Correspondent
Lifeguard Medical Products, Inc.
400 Lathrop Ave.
Suite 200
River Forest,  IL  60305
Correspondent Contact DOUGLAS HULFISH
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/15/1991
Decision Date 01/23/1992
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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