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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K942017
Device Name V-PRIMER
Applicant
Parkell, Inc.
155 Schmitt Blvd.
P.O. Box 376
Farmingdale,  NY  11735
Applicant Contact NELSON J GENDUSA
Correspondent
Parkell, Inc.
155 Schmitt Blvd.
P.O. Box 376
Farmingdale,  NY  11735
Correspondent Contact NELSON J GENDUSA
Regulation Number872.3200
Classification Product Code
KLE  
Date Received04/26/1994
Decision Date 07/06/1994
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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