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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 K032179
Device Name COMP. E
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  
Subsequent Product Code
EBI  
Date Received07/14/2003
Decision Date 09/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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