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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 K171872
Device Name P50 Series Dental Operative Unit and Accessories
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 Received06/23/2017
Decision Date 04/26/2018
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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