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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 K863484
Device Name SIEMENS SIRONA(R) DENTAL CHAIR
Applicant
Pelton & Crane Co.
P.O. Box 7800
Charlotte,  NC  28241
Applicant Contact PHILIP L WHITSON
Correspondent
Pelton & Crane Co.
P.O. Box 7800
Charlotte,  NC  28241
Correspondent Contact PHILIP L WHITSON
Regulation Number872.6250
Classification Product Code
KLC  
Date Received09/09/1986
Decision Date 09/19/1986
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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