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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 Tray, Resin
510(k) Number K930487
Device Name PALATRAY LC MINT
Applicant
Heraeus Kulzer, Inc.
10005 Muirlands Blvd.
Irvine,  CA  92718 -2595
Applicant Contact SHARON PARKER
Correspondent
Heraeus Kulzer, Inc.
10005 Muirlands Blvd.
Irvine,  CA  92718 -2595
Correspondent Contact SHARON PARKER
Regulation Number872.3670
Classification Product Code
EBH  
Date Received01/29/1993
Decision Date 06/18/1993
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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