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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Chair, Dental, With Operative Unit
510(k) Number K942870
Device Name ULTIMA 2 DENTAL CHAIR
Applicant
Dentech Corp.
529 W. Front St.
Sumas,  WA  98295
Applicant Contact GARY VILLETTE
Correspondent
Dentech Corp.
529 W. Front St.
Sumas,  WA  98295
Correspondent Contact GARY VILLETTE
Regulation Number872.6250
Classification Product Code
KLC  
Date Received06/17/1994
Decision Date 02/27/1995
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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