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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K980968
Device Name LONE STAR IMPRESSION SYSTEMS
Applicant
Lone Star Technologies
31 Runnymeade
Chatham,  NJ  07928
Applicant Contact EDWARD SPEHAR
Correspondent
Lone Star Technologies
31 Runnymeade
Chatham,  NJ  07928
Correspondent Contact EDWARD SPEHAR
Regulation Number872.3660
Classification Product Code
ELW  
Date Received03/16/1998
Decision Date 06/09/1998
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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