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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 K030940
FOIA Releasable 510(k) K030940
Device Name NOMAD ND1000M AUGMENTED VISION SYSTEM
Applicant
Microvision Incorporated
19910 N. Creek Pkwy.
Bothell,  WA  98011
Applicant Contact KARL BYLUND
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607
Correspondent Contact CHARLES MACK
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/25/2003
Decision Date 04/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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