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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)
510(k) Number K790554
Device Name EXETER LIP SEAL
Applicant
EXETER MEDICAL LABS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
EXETER MEDICAL LABS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Classification Product Code
LFA  
Date Received03/19/1979
Decision Date 04/10/1979
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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