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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser For Gastro-Urology Use
510(k) Number K874253
Device Name ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.
Applicant
Minnesota Laser Corp.
6470 Riverview Terrace NE
Minneapolis,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
Minnesota Laser Corp.
6470 Riverview Terrace NE
Minneapolis,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number878.4810
Classification Product Code
LNK  
Date Received10/20/1987
Decision Date 07/12/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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