510(k) K150748

Flexipet Denuding Pipette, Flexipet Manipulation Pipette by Cook Incorporated — Product Code MQH

K150748 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Flexipet Denuding Pipette, Flexipet Manipulation Pipette". The FDA issued a decision of Substantially Equivalent on December 18, 2015. The device falls under product code MQH (Microtools, Assisted Reproduction (Pipettes)), a Class II device regulated under 21 CFR 884.6130. Cook Incorporated has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2015
Date Received
March 23, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microtools, Assisted Reproduction (Pipettes)
Device Class
Class II
Regulation Number
884.6130
Review Panel
OB
Submission Type