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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 K844869
Device Name FIBERLASE 100 MEDICAL LASER SYSTEM
Applicant
LASER MEDIA
77 ARKAY DR.
HAUPPAUGE,  NY  11788
Applicant Contact ROBERT A KAPLAN
Correspondent
LASER MEDIA
77 ARKAY DR.
HAUPPAUGE,  NY  11788
Correspondent Contact ROBERT A KAPLAN
Regulation Number874.4500
Classification Product Code
LLO  
Date Received12/14/1984
Decision Date 01/14/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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