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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Elastomer, Silicone Block
510(k) Number K955370
Device Name DURALASTIC II
Applicant
Allied Biomedical Corp.
118-D Springhall Dr.
Goose Creek,  SC  29445
Applicant Contact GERALD HANSON
Correspondent
Allied Biomedical Corp.
118-D Springhall Dr.
Goose Creek,  SC  29445
Correspondent Contact GERALD HANSON
Regulation Number874.3620
Classification Product Code
MIB  
Date Received11/22/1995
Decision Date 02/08/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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