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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burnisher, Operative
510(k) Number K885040
Device Name DENTAL MIRROR RETRACTOR
Applicant
Nu-Lite Retractor, Inc.
108-18 72nd Ave., Suite 6
Forest Hills,  NY  11375
Applicant Contact GERSHON, DDS
Correspondent
Nu-Lite Retractor, Inc.
108-18 72nd Ave., Suite 6
Forest Hills,  NY  11375
Correspondent Contact GERSHON, DDS
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received12/05/1988
Decision Date 01/10/1989
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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