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510(k) K172179

Chitogel Endoscopic Sinus Surgery Kit by Chitogel, Ltd. — Product Code LYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2017
Date Received
July 19, 2017
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

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