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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K945711
Device Name EXCEL-P FORMULA AUTO-CURE DENTURE BASE
Applicant
St. George Technology, Inc.
P.O. Box 1586
York,  PA  17405
Applicant Contact VERNON WATKINS
Correspondent
St. George Technology, Inc.
P.O. Box 1586
York,  PA  17405
Correspondent Contact VERNON WATKINS
Regulation Number872.3760
Classification Product Code
EBI  
Date Received11/21/1994
Decision Date 02/02/1995
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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