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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 K924422
Device Name PALABOND
Applicant
Heraeus Kulzer, Inc.
10005 Muirlands Blvd.
Irvine,  CA  92718
Applicant Contact SHARON PARKER
Correspondent
Heraeus Kulzer, Inc.
10005 Muirlands Blvd.
Irvine,  CA  92718
Correspondent Contact SHARON PARKER
Regulation Number872.3760
Classification Product Code
EBI  
Date Received09/01/1992
Decision Date 11/04/1992
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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