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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Caries Detection
510(k) Number K973200
Device Name CARIES STAIN
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 Number872.1740
Classification Product Code
LFC  
Date Received08/26/1997
Decision Date 11/06/1997
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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