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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Fiber Optic, Dental
510(k) Number K935718
Device Name JEDENTAL VLC DENTAL CURING LIGHT
Applicant
Jedental Co., Inc.
324 Second St. Pike
Southampton,  PA  18966
Applicant Contact JOHN WONG
Correspondent
Jedental Co., Inc.
324 Second St. Pike
Southampton,  PA  18966
Correspondent Contact JOHN WONG
Regulation Number872.4620
Classification Product Code
EAY  
Date Received11/30/1993
Decision Date 01/26/1994
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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