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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 K010800
Device Name VERSYO.COM
Applicant
Heraeus Kulzer, Inc.
99 Business Park Dr.
Armonk,  NY  10504
Applicant Contact RAPHAEL JUDKINS
Correspondent
Heraeus Kulzer, Inc.
99 Business Park Dr.
Armonk,  NY  10504
Correspondent Contact RAPHAEL JUDKINS
Regulation Number872.3760
Classification Product Code
EBI  
Date Received03/16/2001
Decision Date 05/31/2001
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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