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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Catheter, Fiberoptic, Glass, Ureteral
510(k) Number K880071
Device Name SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE
Applicant
Laserguide
51 Santa Felicia Dr.
Santa Barbara,  CA  93117
Applicant Contact PAMELA GORFORTH
Correspondent
Laserguide
51 Santa Felicia Dr.
Santa Barbara,  CA  93117
Correspondent Contact PAMELA GORFORTH
Regulation Number876.4020
Classification Product Code
FCS  
Date Received01/11/1988
Decision Date 03/22/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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