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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane
510(k) Number K771615
Device Name AUDI-SIL EARMOLD MATERIAL
Applicant
Coe Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Coe Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number874.3620
Classification Product Code
ESH  
Date Received08/24/1977
Decision Date 08/30/1977
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
Predetermined Change
Control Plan Authorized		 No
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