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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Caloric-Air
510(k) Number K946108
Device Name EAR-A-GATOR
Applicant
LIFE-TECH INTL., INC.
P.O. BOX 36221
HOUSTON,  TX  77236 -6221
Applicant Contact ALFRED C COATS
Correspondent
LIFE-TECH INTL., INC.
P.O. BOX 36221
HOUSTON,  TX  77236 -6221
Correspondent Contact ALFRED C COATS
Regulation Number874.1800
Classification Product Code
KHH  
Date Received12/14/1994
Decision Date 06/13/1995
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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