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510(k) K011383

MICRODOSE CATH, MODELS 90121-201, -202, -203 by Durect Corp. — Product Code ETD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2001
Date Received
May 7, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tympanostomy
Device Class
Class II
Regulation Number
874.3880
Review Panel
EN
Submission Type

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