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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 K915297
Device Name TROCAR & TROCAR SLEEEVE 11MM, 10MM, 8MM & 5MM
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 Number884.1720
Classification Product Code
HET  
Date Received11/15/1991
Decision Date 02/11/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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