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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 K760404
Device Name BI-CENTRIC SYSTEM
Applicant
PELTON & CRANE CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PELTON & CRANE CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number872.6250
Classification Product Code
KLC  
Date Received08/09/1976
Decision Date 08/23/1976
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
Recalls CDRH Recalls
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