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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 K852761
Device Name CILAS MODEL YM101
Applicant
INFRAMED, INC.
P.O. BOX 761
BROOKLINE VILLAGE,  MA  02147
Applicant Contact RAYMOND F FENNESSEY
Correspondent
INFRAMED, INC.
P.O. BOX 761
BROOKLINE VILLAGE,  MA  02147
Correspondent Contact RAYMOND F FENNESSEY
Regulation Number874.4500
Classification Product Code
LLO  
Date Received06/28/1985
Decision Date 11/14/1985
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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