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510(k) K002709

RACE ENDODONTIC FILE by Amc General, Inc. — Product Code EFA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2000
Date Received
August 30, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Belt And/Or Gear Driven, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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