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510(k) K092590

PDS PLATES by Ethicon, Inc. — Product Code NHB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2010
Date Received
August 24, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Device Class
Class II
Regulation Number
874.3620
Review Panel
EN
Submission Type

Ear, nose, and throat absorbable synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is shaped and formed by the surgeon to conform to the patient's needs. This generic type of device is made of absorbable synthetic polymer materials.

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