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510(k) K171872

P50 Series Dental Operative Unit and Accessories by Pelton & Crane — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2018
Date Received
June 23, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Operative Dental
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type

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