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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Rigid
510(k) Number K901464
Device Name MEDILASE SERIES 2200 ENDOSCOPE
Applicant
Medical Laser, Inc.
2605 Fernbrook Ln.
Minneapolis,  MN  55447
Applicant Contact SHARON KARR
Correspondent
Medical Laser, Inc.
2605 Fernbrook Ln.
Minneapolis,  MN  55447
Correspondent Contact SHARON KARR
Regulation Number876.1500
Classification Product Code
GCM  
Date Received03/28/1990
Decision Date 08/07/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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