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510(k) K000366

FIXATION STYLETS, MODELS 335-287 AND 335-288 by Accufix Research Institute — Product Code DRB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2000
Date Received
February 4, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stylet, Catheter
Device Class
Class II
Regulation Number
870.1380
Review Panel
CV
Submission Type

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