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510(k) K181546

Dillard Nasal Balloon Catheter by Intuit Medical Products, LLC — Product Code LRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2020
Date Received
June 12, 2018
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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