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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 K895134
Device Name 3M INSTANT FIT CUSTOM EARMOLD
Applicant
3M COMPANY
CHEMOLITE BLVD. & WASHINGTON
CITY RD. 19
COTTAE GROVE,  MN  55016
Applicant Contact DEANNA OLIVEIRA
Correspondent
3M COMPANY
CHEMOLITE BLVD. & WASHINGTON
CITY RD. 19
COTTAE GROVE,  MN  55016
Correspondent Contact DEANNA OLIVEIRA
Regulation Number874.3300
Classification Product Code
ESD  
Date Received08/16/1989
Decision Date 10/24/1989
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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