510(k) K790339

CONCEPT II by Richardson Merrel, Inc. — Product Code EBE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1979
Date Received
February 21, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coating, Denture Hydrophilic, Resin
Device Class
Class II
Regulation Number
872.3300
Review Panel
DE
Submission Type