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510(k) K864139

RANFAC CUT BIOPSY NEEDLE by Ranfac, Corp. — Product Code GAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1986
Date Received
October 22, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Aspiration And Injection, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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  • K961922 — RDP-2 (August 9, 1996)
  • K951090 — INTRODUCER (July 11, 1995)
  • K930474 — NEEDLE, PNEUMOPERITONEUM, SPRING LOADED (July 23, 1993)

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  • K945109 — MONOJECT BONE MARROW BIOPSY TRAYS (November 14, 1994)
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