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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Inflation, Middle Ear
510(k) Number K951596
Device Name EARCLEAR
Applicant
Arisil Medical
450 Clinton St.
Brooklyn,  NY  11231
Applicant Contact DANIEL S ARICK
Correspondent
Arisil Medical
450 Clinton St.
Brooklyn,  NY  11231
Correspondent Contact DANIEL S ARICK
Classification Product Code
MJV  
Date Received04/07/1995
Decision Date 05/24/1995
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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