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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Block, Bite
510(k) Number K941856
Device Name PREMIER PROMAX BITE GUARD
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 Number882.5070
Classification Product Code
JXL  
Date Received04/15/1994
Decision Date 04/05/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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