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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K143696
Device Name Spirit
Applicant
Pelton & Crane
11727 Fruehauf Dr.
Charlotte,  NC  28273
Applicant Contact Frank Ray
Correspondent
Pelton & Crane
11727 Fruehauf Dr.
Charlotte,  NC  28273
Correspondent Contact Frank Ray
Regulation Number872.6640
Classification Product Code
EIA  
Date Received12/24/2014
Decision Date 09/18/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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