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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Pulp
510(k) Number K950237
Device Name DIGITEST
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 Number872.1720
Classification Product Code
EAT  
Date Received01/20/1995
Decision Date 06/09/1995
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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