510(k) K854765

INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH by C&C Systems, Inc. — Product Code EHP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1986
Date Received
November 27, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clasp, Preformed
Device Class
Class I
Regulation Number
872.3285
Review Panel
DE
Submission Type