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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name locator, root apex
510(k) Number K002195
Device Name FORAMATRON V, MODEL D680
Applicant
PARKELL, INC.
155 SCHMITT BLVD.
P.O. BOX 376
FARMINGDALE,  NY  11735
Applicant Contact DANIEL R SCHECHTER
Correspondent
PARKELL, INC.
155 SCHMITT BLVD.
P.O. BOX 376
FARMINGDALE,  NY  11735
Correspondent Contact DANIEL R SCHECHTER
Classification Product Code
LQY  
Date Received07/20/2000
Decision Date 08/30/2000
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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