510(k) K912418

SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE by Micromedics, Inc. — Product Code KAM

K912418 is an FDA 510(k) premarket notification submitted by Micromedics, Inc. for the device "SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE". The FDA issued a decision of Substantially Equivalent on December 20, 1991. The device falls under product code KAM (Cannula, Sinus), a Class I device regulated under 21 CFR 878.4800. Micromedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1991
Date Received
May 31, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Sinus
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type