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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 K992609
Device Name HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400
Applicant
Kay See Dental Mfg. Co.
124 E. Missouri Ave.
Kansas City,  MO  64106
Applicant Contact CLARK SMITH
Correspondent
Kay See Dental Mfg. Co.
124 E. Missouri Ave.
Kansas City,  MO  64106
Correspondent Contact CLARK SMITH
Regulation Number872.3760
Classification Product Code
EBI  
Date Received08/04/1999
Decision Date 09/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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