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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 K964867
Device Name HYBRID RESIN COMPOSITE
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 Received12/05/1996
Decision Date 04/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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