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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 K940950
Device Name KAVO SYSTEMATICA 1060
Applicant
Kavo America
340 E. Main St.
Lake Zurich,  IL  60047
Applicant Contact EDWARD STOGENSON
Correspondent
Kavo America
340 E. Main St.
Lake Zurich,  IL  60047
Correspondent Contact EDWARD STOGENSON
Regulation Number872.6250
Classification Product Code
KLC  
Date Received02/28/1994
Decision Date 12/29/1994
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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