510(k) K182002

Cumulus Remover by Kitazato Corporation — Product Code MQL

K182002 is an FDA 510(k) premarket notification submitted by Kitazato Corporation for the device "Cumulus Remover". The FDA issued a decision of Substantially Equivalent on October 23, 2018. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Kitazato Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2018
Date Received
July 26, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Reproductive
Device Class
Class II
Regulation Number
884.6180
Review Panel
OB
Submission Type