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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hearing aid, air-conduction, prescription
510(k) Number K893721
Device Name LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT
Applicant
LORI MEDICAL LABORATORIES, INC.
P.O. BOX 302
LONG LAKE,  MN  55356
Applicant Contact RICHARD R MAAS
Correspondent
LORI MEDICAL LABORATORIES, INC.
P.O. BOX 302
LONG LAKE,  MN  55356
Correspondent Contact RICHARD R MAAS
Regulation Number874.3300
Classification Product Code
ESD  
Date Received05/17/1989
Decision Date 09/08/1989
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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