510(k) K141704

NOVASHIELD INJECTABLE NASAL PACKING AND STENT by Medtronic, Inc. — Product Code LYA

K141704 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "NOVASHIELD INJECTABLE NASAL PACKING AND STENT". The FDA issued a decision of Substantially Equivalent on October 6, 2014. The device falls under product code LYA (Splint, Intranasal Septal), a Class I device regulated under 21 CFR 874.4780. Medtronic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2014
Date Received
June 24, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Intranasal Septal
Device Class
Class I
Regulation Number
874.4780
Review Panel
EN
Submission Type