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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
Applicant Contact DOUGLAS KWART
Correspondent
Leisegang Medical, Inc.
6401 Congress Ave.
Boca Raton,  FL  33487
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
Predetermined Change
Control Plan Authorized		 No
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