510(k) K833485

IMPRESSION TUBE ADJUSTABLE by Zefr, Inc. — Product Code EHY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 1983
Date Received
October 7, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Impression, Preformed
Device Class
Class I
Regulation Number
872.6880
Review Panel
DE
Submission Type