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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activator, Ultraviolet, For Polymerization
510(k) Number K951465
Device Name SUNLITE 1275
Applicant
Fen Dental Mfg., Inc.
1819 S. May St., 2f
Chicago,  IL  60608
Applicant Contact ROBERT W BAUER
Correspondent
Fen Dental Mfg., Inc.
1819 S. May St., 2f
Chicago,  IL  60608
Correspondent Contact ROBERT W BAUER
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received03/30/1995
Decision Date 05/31/1995
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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