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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 K953419
Device Name LOS 3D VISION 100
Applicant
LASER OPTIK SYSTEME GMBH & CO. KG
AM SAGEWERK 11
AMTSGERICHT MAINZ HRB 4527
MAINZ,  DE 55124
Correspondent
LASER OPTIK SYSTEME GMBH & CO. KG
AM SAGEWERK 11
AMTSGERICHT MAINZ HRB 4527
MAINZ,  DE 55124
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/03/1995
Decision Date 02/08/1996
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
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