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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical Headlight
510(k) Number K923949
Device Name SYLVAN DENTAL HEADLIGHT SYSTEM
Applicant
Sylvan Medical Fiberoptics
1061 Main St.
Suite 2e3
North Huntingdon,  PA  15642
Applicant Contact JAMES GEDORKA
Correspondent
Sylvan Medical Fiberoptics
1061 Main St.
Suite 2e3
North Huntingdon,  PA  15642
Correspondent Contact JAMES GEDORKA
Regulation Number872.4630
Classification Product Code
EBA  
Date Received08/05/1992
Decision Date 10/16/1992
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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