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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 K880592
Device Name LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE
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 Number874.4500
Classification Product Code
LLO  
Date Received02/11/1988
Decision Date 04/25/1988
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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