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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 K972553
Device Name LANG DENTAL RESIN A97 FIBRED PINK
Applicant
Lang Dental Mfg. Co., Inc.
175 Messner Dr.
Wheeling,  IL  60090
Applicant Contact CHAH M SHEN
Correspondent
Lang Dental Mfg. Co., Inc.
175 Messner Dr.
Wheeling,  IL  60090
Correspondent Contact CHAH M SHEN
Regulation Number872.3760
Classification Product Code
EBI  
Date Received07/08/1997
Decision Date 11/13/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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