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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ent Microsurgical Carbon-Dioxide
510(k) Number K860975
Device Name MODEL 545-45 LASER FOR EAR, NOSE & THROAT
Applicant
BRITT CORP., INC.
2231 SOUTH BARRINGTON AVE.
LOS ANGELES,  CA  90064
Applicant Contact JEFFREY GREEN
Correspondent
BRITT CORP., INC.
2231 SOUTH BARRINGTON AVE.
LOS ANGELES,  CA  90064
Correspondent Contact JEFFREY GREEN
Regulation Number874.4500
Classification Product Code
EWG  
Date Received03/14/1986
Decision Date 07/18/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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