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510(k) K844769

RIGID FIBEROPITC ENDOSCOPE by Microvasive — Product Code GCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1985
Date Received
December 7, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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  • K861309 — JEJUNAL FEEDING TUBE (December 16, 1986)
  • K860589 — INFLATOR/DEFLATOR PISTON SYRINGE (April 7, 1986)
  • K860366 — CHALLENGER HOT BIOPSY FORCEPS (April 7, 1986)
  • K854238 — NEEDLE W/STYLET FOR IMPLANTATION (November 13, 1985)
  • K854063 — MICROVASIVE SILICONE SPRAY (October 25, 1985)
  • K851652 — PAPILLOTOME (June 24, 1985)
  • K850393 — FLEXIBLE FIBEROPTIC ENDOSCOPE (June 4, 1985)

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