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510(k) K860589

INFLATOR/DEFLATOR PISTON SYRINGE by Microvasive — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1986
Date Received
February 19, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Microvasive

  • K872771 — LOW PROFILE GASTROSTOMY (October 9, 1987)
  • K870705 — THERMAL COAGULATOR (April 17, 1987)
  • K861323 — REPLACEMENT GASTROSTOMY TUBE (December 16, 1986)
  • K861309 — JEJUNAL FEEDING TUBE (December 16, 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)
  • K844769 — RIGID FIBEROPITC ENDOSCOPE (January 15, 1985)

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