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510(k) K771108

NEEDLE, CHIBA UNIVERSITY by Johannah Medical Services, Inc. — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1977
Date Received
June 20, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biopsy Needle
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
Submission Type

Other clearances by Johannah Medical Services, Inc.

  • K801304 — CAMLOC SYRINGE BIOPSY KIT (June 17, 1980)
  • K791643 — BONE MARROW NEEDLE (September 12, 1979)
  • K770370 — CONVENIENCE TRAY (March 16, 1977)

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  • K212822 — Disposable Coaxial Biopsy Needle (July 6, 2022)
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