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510(k) K172737

MESIRE - Balloon Sinus Dilatation System by M/S. Meril Life Sciences Private Limited — Product Code LRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2017
Date Received
September 11, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Ent Manual Surgical
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

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