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510(k) K974794

WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY NEEDLE by Worldwide Medical Technologies, LLC — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1998
Date Received
December 22, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type

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  • K981889 — WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE (July 31, 1998)
  • K982097 — WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD (June 25, 1998)

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