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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 K072613
Device Name DIRECTVIEW, LIGHTGUIDE, MODEL(S) 10RLL-320 LAPAROSCOPE, 10DLG-320 DISPOSABLE LIGHT GUIDE FOR ABOVE
Applicant
Micro Invasive Technology, Inc.
934 N. Main St.
Danielson,  CT  06239
Applicant Contact JOHN BALA
Correspondent
Micro Invasive Technology, Inc.
934 N. Main St.
Danielson,  CT  06239
Correspondent Contact JOHN BALA
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/17/2007
Decision Date 04/21/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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