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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 K874680
Device Name LASEGUIDE 600A, 600B, 400A, AND 400B
Applicant
LASER PERIPHERALS LLC.
35 POND PARK RD. #9
HINGHAM,  MA  02043
Applicant Contact MICHAEL N BASEL
Correspondent
LASER PERIPHERALS LLC.
35 POND PARK RD. #9
HINGHAM,  MA  02043
Correspondent Contact MICHAEL N BASEL
Regulation Number876.4020
Classification Product Code
FCS  
Date Received11/13/1987
Decision Date 03/23/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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