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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscope, battery-powered and accessories
510(k) Number K924134
Device Name LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS
Applicant
LEISEGANG MEDICAL, INC.
6401 CONGRESS AVE.
BOCA RATON,  FL  33487 -2883
Applicant Contact DOUGLAS KWART
Correspondent
LEISEGANG MEDICAL, INC.
6401 CONGRESS AVE.
BOCA RATON,  FL  33487 -2883
Correspondent Contact DOUGLAS KWART
Regulation Number876.1500
Classification Product Code
GCS  
Date Received08/18/1992
Decision Date 07/02/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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