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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 K954160
Device Name MSV-2000 VIDEO IMAGING SYSTEM
Applicant
Applitec, Ltd.
12 Ha'Orgim St.
P.O. Box 501
Holon,  IL 58105
Applicant Contact BORIS ARADOVSKY
Correspondent
Applitec, Ltd.
12 Ha'Orgim St.
P.O. Box 501
Holon,  IL 58105
Correspondent Contact BORIS ARADOVSKY
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/05/1995
Decision Date 12/04/1995
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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