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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 K930965
Device Name LOS 3D VISION 100
Applicant
Laser Optik Systeme GmbH & Co. KG
Am Sagewerk 11,6500 Mainz 23
Amtsgericht Mainz Hrb 4527
Germany,  DE
Applicant Contact MARC STRELOW
Correspondent
Laser Optik Systeme GmbH & Co. KG
Am Sagewerk 11,6500 Mainz 23
Amtsgericht Mainz Hrb 4527
Germany,  DE
Correspondent Contact MARC STRELOW
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/24/1993
Decision Date 04/11/1994
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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