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510(k) K183438

Geomed Vascular Dilators by Geomed Medizin-Technik GmbH & Co. — Product Code DWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2019
Date Received
December 12, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, Surgical
Device Class
Class II
Regulation Number
870.4475
Review Panel
CV
Submission Type

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