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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 K884830
Device Name DENTAL CHAIR F1
Applicant
Fimet OY
2101 L St. NW
Washington,  DC  20037
Applicant Contact RODNEY R MUNSEY
Correspondent
Fimet OY
2101 L St. NW
Washington,  DC  20037
Correspondent Contact RODNEY R MUNSEY
Regulation Number872.6250
Classification Product Code
KLC  
Date Received11/18/1988
Decision Date 02/10/1989
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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