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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Neurosurgical
510(k) Number K864166
Device Name 25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY
Applicant
Weck Surgical Systems
686 Old Willets Path
Hauppauge,  NY  11788
Applicant Contact ZBIGNIEW DROZDOWICZ
Correspondent
Weck Surgical Systems
686 Old Willets Path
Hauppauge,  NY  11788
Correspondent Contact ZBIGNIEW DROZDOWICZ
Classification Product Code
LKW  
Date Received10/23/1986
Decision Date 02/10/1987
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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