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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 K132526
Device Name KNIT-PAK+
Applicant
PREMIER DENTAL PRODUCTS CO.
1710 ROMANO DR.
PLYMOUTH MEETING,  PA  19462
Applicant Contact VINCENT D'ALLESANDRO
Correspondent
PREMIER DENTAL PRODUCTS CO.
1710 ROMANO DR.
PLYMOUTH MEETING,  PA  19462
Correspondent Contact VINCENT D'ALLESANDRO
Classification Product Code
MVL  
Date Received08/12/2013
Decision Date 11/26/2013
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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