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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 K961995
Device Name QUICKSPLINT
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 Number872.3760
Classification Product Code
EBI  
Date Received05/21/1996
Decision Date 06/26/1996
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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