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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K883642
Device Name CODMAN NEUROLASE LASER SYSTEM
Applicant
I.L. Med, Inc.
591b Providence Hwy.
Walpole,  MA  02081
Applicant Contact RONALD L MADDIX
Correspondent
I.L. Med, Inc.
591b Providence Hwy.
Walpole,  MA  02081
Correspondent Contact RONALD L MADDIX
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/23/1988
Decision Date 10/20/1988
Decision Substantially Equivalent (SESE)
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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