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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Zinc Oxide Eugenol
510(k) Number K941066
Device Name DENTAL 911
Applicant
L.A.F. Industries, Inc.
923 Fifth Ave. Suite 1c
New York,  NY  10021
Applicant Contact LLOYD A FEINBERG
Correspondent
L.A.F. Industries, Inc.
923 Fifth Ave. Suite 1c
New York,  NY  10021
Correspondent Contact LLOYD A FEINBERG
Regulation Number872.3275
Classification Product Code
EMB  
Date Received03/08/1994
Decision Date 05/24/1995
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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