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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Audiometer
510(k) Number K895200
Device Name MODEL EB-22 NOISE STIK
Applicant
ECKSTEIN BROTHERS, INC.
4807 WEST 118TH PLACE
HAWTHORNE (L.A.),  CA  90250
Applicant Contact LEO H ECKSTEIN
Correspondent
ECKSTEIN BROTHERS, INC.
4807 WEST 118TH PLACE
HAWTHORNE (L.A.),  CA  90250
Correspondent Contact LEO H ECKSTEIN
Regulation Number874.1050
Classification Product Code
EWO  
Date Received08/18/1989
Decision Date 01/22/1990
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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