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510(k) K982097

WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD by Worldwide Medical Technologies, LLC — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1998
Date Received
June 15, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

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  • K991344 — WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS (November 5, 1999)
  • K981889 — WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE (July 31, 1998)
  • K981470 — WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE (June 19, 1998)

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