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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Operating, Dental
510(k) Number K874374
Device Name THE WOOG ORATEST
Applicant
Woog Intl.
1848 Charter Ln., Suite C
Lancaster,  PA  17601
Applicant Contact HELLER, JR
Correspondent
Woog Intl.
1848 Charter Ln., Suite C
Lancaster,  PA  17601
Correspondent Contact HELLER, JR
Regulation Number872.4630
Classification Product Code
EAZ  
Date Received10/26/1987
Decision Date 01/19/1988
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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