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510(k) K854238

NEEDLE W/STYLET FOR IMPLANTATION by Microvasive — Product Code GAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1985
Date Received
October 21, 1985
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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  • K860366 — CHALLENGER HOT BIOPSY FORCEPS (April 7, 1986)
  • K854063 — MICROVASIVE SILICONE SPRAY (October 25, 1985)
  • K851652 — PAPILLOTOME (June 24, 1985)
  • K850393 — FLEXIBLE FIBEROPTIC ENDOSCOPE (June 4, 1985)
  • K844769 — RIGID FIBEROPITC ENDOSCOPE (January 15, 1985)

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