510(k) K935906

RANIR PLAX RX by Ranir/Dcp Corp. — Product Code EAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1994
Date Received
December 10, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mirror, Mouth
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type