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510(k) K000409

MODIFICATION TO T-REX BIOPSY FORCEPS by Boston Scientific Corp — Product Code DWZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2000
Date Received
February 8, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biopsy, Endomyocardial
Device Class
Class II
Regulation Number
870.4075
Review Panel
CV
Submission Type

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