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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cord, retraction
510(k) Number K083695
Device Name TRAXODENT
Applicant
PREMIER DENTAL PRODUCTS CO.
1710 ROMANO DR.
PLYMOUTH MEETING,  PA  19462
Applicant Contact VINCENT D'ALESSANDRO
Correspondent
PREMIER DENTAL PRODUCTS CO.
1710 ROMANO DR.
PLYMOUTH MEETING,  PA  19462
Correspondent Contact VINCENT D'ALESSANDRO
Classification Product Code
MVL  
Date Received12/15/2008
Decision Date 04/28/2009
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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