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510(k) K181696

ChitoZolve by Gyrus Acmi, Inc. — Product Code LYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2018
Date Received
June 27, 2018
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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