510(k) K760985

HAND INSTRUMENTS by Adp Intl., Inc. — Product Code EKW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1976
Date Received
October 21, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Broach, Endodontic
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type