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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 K013701
Device Name ENDO-GLIDE
Applicant
Sonotech, Inc.
774 Marine Dr.
Bellingham,  WA  98225
Applicant Contact MARGARET J LARSON
Correspondent
Sonotech, Inc.
774 Marine Dr.
Bellingham,  WA  98225
Correspondent Contact MARGARET J LARSON
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/08/2001
Decision Date 02/04/2002
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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