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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Masker, Tinnitus
510(k) Number K041302
Device Name REFUGE SOUND GENERATOR
Applicant
Micro-Ear Technology, Inc.
3500 Holly Ln. N., #10
Plymouth,  MN  55447
Applicant Contact DEBORAH SHAFFER
Correspondent
Micro-Ear Technology, Inc.
3500 Holly Ln. N., #10
Plymouth,  MN  55447
Correspondent Contact DEBORAH SHAFFER
Regulation Number874.3400
Classification Product Code
KLW  
Date Received05/14/2004
Decision Date 07/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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