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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Impression, Preformed
510(k) Number K850776
Device Name PREFORMED DENTAL IMPRESSION TRAYS
Applicant
L.A.K. Ent., Inc.
Bellsey & Baker
100 California St. #460
San Francisco,  CA  94111
Applicant Contact STEVEN W BAKER
Correspondent
L.A.K. Ent., Inc.
Bellsey & Baker
100 California St. #460
San Francisco,  CA  94111
Correspondent Contact STEVEN W BAKER
Regulation Number872.6880
Classification Product Code
EHY  
Date Received02/26/1985
Decision Date 03/18/1985
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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