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510(k) K131799

QUICKNIT by Microcopy, Div. of Neo-Flo, Inc. — Product Code MVL

K131799 is an FDA 510(k) premarket notification submitted by Microcopy, Div. of Neo-Flo, Inc. for the device "QUICKNIT". The FDA issued a decision of Substantially Equivalent on January 16, 2014. The device falls under product code MVL (Cord, Retraction), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2014
Date Received
June 19, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cord, Retraction
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

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FDA data resources