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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Articulators
510(k) Number K892373
Device Name DENTAL PLASTIC BITE FORK
Applicant
Texapol Corp.
117 Mikron Rd.
Bethlehem,  PA  18017
Applicant Contact R LEVANDOSKI
Correspondent
Texapol Corp.
117 Mikron Rd.
Bethlehem,  PA  18017
Correspondent Contact R LEVANDOSKI
Regulation Number872.3150
Classification Product Code
EJP  
Date Received04/06/1989
Decision Date 06/12/1989
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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