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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K913136
Device Name LASER ENDOSCOPE DISC DECOMPRESSION KITS
Applicant
Medical Laser, Inc.
2605 Fernbrook Ln.
Minneapolis,  MN  55447
Applicant Contact GREGORY J.MATHISON
Correspondent
Medical Laser, Inc.
2605 Fernbrook Ln.
Minneapolis,  MN  55447
Correspondent Contact GREGORY J.MATHISON
Regulation Number878.4370
Classification Product Code
LRO  
Date Received07/16/1991
Decision Date 11/01/1991
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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