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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 K924652
Device Name BENSON CCA100
Applicant
BENSON MEDICAL INSTRUMENTS CO.
137 CECIL ST. SE
MINNEAPOLIS,  MN  55414
Applicant Contact DAVID P MAYOU
Correspondent
BENSON MEDICAL INSTRUMENTS CO.
137 CECIL ST. SE
MINNEAPOLIS,  MN  55414
Correspondent Contact DAVID P MAYOU
Regulation Number874.4500
Classification Product Code
EWG  
Date Received09/15/1992
Decision Date 04/09/1993
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
Predetermined Change
Control Plan Authorized		 No
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