510(k) K895738

MICROMEDICS EAR, NOSE AND THROAT BURS by Micromedics, Inc. — Product Code EQJ

K895738 is an FDA 510(k) premarket notification submitted by Micromedics, Inc. for the device "MICROMEDICS EAR, NOSE AND THROAT BURS". The FDA issued a decision of Substantially Equivalent on December 19, 1989. The device falls under product code EQJ (Bur, Ear, Nose And Throat), a Class I device regulated under 21 CFR 874.4140. Micromedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1989
Date Received
September 26, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bur, Ear, Nose And Throat
Device Class
Class I
Regulation Number
874.4140
Review Panel
EN
Submission Type