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510(k) K973818

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1997
Date Received
October 7, 1997
Clearance Type
Traditional
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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