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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 K905511
Device Name CODMAN NEUROLASE LASER SYSTEM/MODIFICATION
Applicant
I.L. Med, Inc.
591b Providence Hwy.
Walpole,  MA  02081
Applicant Contact IGINO LOMBARDO
Correspondent
I.L. Med, Inc.
591b Providence Hwy.
Walpole,  MA  02081
Correspondent Contact IGINO LOMBARDO
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/07/1990
Decision Date 03/05/1991
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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