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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Examining/Treatment, Ent
510(k) Number K945395
Device Name PREMIER MIRROR WARMER
Applicant
Premier Dental Products Co.
10090 Sandmeyer Ln.
Philadelphia,  PA  19116
Applicant Contact WILLIAM J FREZEL
Correspondent
Premier Dental Products Co.
10090 Sandmeyer Ln.
Philadelphia,  PA  19116
Correspondent Contact WILLIAM J FREZEL
Regulation Number874.5300
Classification Product Code
ETF  
Date Received11/03/1994
Decision Date 01/18/1995
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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