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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Neodymium:Yag, Pulmonary Surgery
510(k) Number K875104
Device Name SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE
Applicant
Laserguide
51 Santa Felicia Dr.
Santa Barbara,  CA  93117
Applicant Contact ROBERT C MICHAELS
Correspondent
Laserguide
51 Santa Felicia Dr.
Santa Barbara,  CA  93117
Correspondent Contact ROBERT C MICHAELS
Regulation Number874.4500
Classification Product Code
LLO  
Date Received12/18/1987
Decision Date 02/02/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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