510(k) K850776

PREFORMED DENTAL IMPRESSION TRAYS by L.A.K. Ent., Inc. — Product Code EHY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1985
Date Received
February 26, 1985
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