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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protector, Hearing (Insert)
510(k) Number K821187
Device Name MEDCO CUSTOM EAR PROTECTOR MOLD KIT
Applicant
Santa Barbara Medco, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Santa Barbara Medco, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Classification Product Code
EWD  
Date Received04/27/1982
Decision Date 05/27/1982
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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