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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 K884918
Device Name PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER
Applicant
PARKELL
155 SCHMITT BLVD.
P.O. BOX 376
FARMINGDALE,  NY  11735
Applicant Contact NELSON J GENDUSA
Correspondent
PARKELL
155 SCHMITT BLVD.
P.O. BOX 376
FARMINGDALE,  NY  11735
Correspondent Contact NELSON J GENDUSA
Regulation Number872.3200
Classification Product Code
KLE  
Date Received11/28/1988
Decision Date 02/13/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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