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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K896719
Device Name PRIMER-P ADHESIVE AGENT
Applicant
Parkell
155 Schmitt Blvd.
P.O. Box 376
Farmingdale,  NY  11735
Applicant Contact J GENDUSA,DDS
Correspondent
Parkell
155 Schmitt Blvd.
P.O. Box 376
Farmingdale,  NY  11735
Correspondent Contact J GENDUSA,DDS
Regulation Number872.3760
Classification Product Code
EBI  
Date Received11/29/1989
Decision Date 02/22/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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