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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K003265
Device Name CLEANAIR/ CLEANWATER UNIT, MODEL 1600
Applicant
TEXAS INSTITUTE FOR CONSERVATIVE DENTISTRY
702 OSAGE ST.
REFUGIO,  TX  78377
Applicant Contact H.O. PIPKIN
Correspondent
TEXAS INSTITUTE FOR CONSERVATIVE DENTISTRY
702 OSAGE ST.
REFUGIO,  TX  78377
Correspondent Contact H.O. PIPKIN
Regulation Number872.6640
Classification Product Code
EIA  
Date Received10/18/2000
Decision Date 12/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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