510(k) K800847

ENTELLAN by Mcb Manufacturing Chemists, Inc. — Product Code KEP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1980
Date Received
April 15, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Mounting, Oil Soluble
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type