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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Carver, Wax, Dental
510(k) Number K902653
Device Name PDS-2000
Applicant
Intl. Equipment and Supply Corp.
3637 N. Meridian St.
Indianapolis,  IN  46208
Applicant Contact JAMES R BAILEY
Correspondent
Intl. Equipment and Supply Corp.
3637 N. Meridian St.
Indianapolis,  IN  46208
Correspondent Contact JAMES R BAILEY
Regulation Number872.4565
Classification Product Code
EIK  
Date Received06/15/1990
Decision Date 09/13/1990
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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