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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 K875042
Device Name ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY
Applicant
SURGILASE, INC.
I-95 CORPORATE PARK
33 PLAN WAY
WARWICK,  RI  02866
Applicant Contact TIMOTHY J SHEA
Correspondent
SURGILASE, INC.
I-95 CORPORATE PARK
33 PLAN WAY
WARWICK,  RI  02866
Correspondent Contact TIMOTHY J SHEA
Classification Product Code
LKW  
Date Received12/07/1987
Decision Date 06/24/1988
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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