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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 -3502
Applicant Contact WILLIAM J FREZEL
Correspondent
PREMIER DENTAL PRODUCTS CO.
10090 SANDMEYER LN.
PHILADELPHIA,  PA  19116 -3502
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
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