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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 K042380
Device Name SILICONE BLOCK
Applicant
National Medical Devices, Inc.
8500 Wilshire Blvd.
Suite 707
Beverly Hills,  CA  90211
Applicant Contact JAMES ELIST
Correspondent
National Medical Devices, Inc.
8500 Wilshire Blvd.
Suite 707
Beverly Hills,  CA  90211
Correspondent Contact JAMES ELIST
Regulation Number874.3620
Classification Product Code
MIB  
Date Received09/01/2004
Decision Date 10/25/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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