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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tester, auditory impedance
510(k) Number K925585
Device Name GSI 38 AUTO TYMP
Applicant
LUCAS GRASON-STADLER, INC.
537 GREAT RD.
P.O. BOX 1400
LITTLETON,  MA  01460
Applicant Contact JANICE E PAINTER
Correspondent
LUCAS GRASON-STADLER, INC.
537 GREAT RD.
P.O. BOX 1400
LITTLETON,  MA  01460
Correspondent Contact JANICE E PAINTER
Regulation Number874.1090
Classification Product Code
ETY  
Date Received11/04/1992
Decision Date 02/02/1993
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
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