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510(k) K923692

STOMA MEASURING DEVICE by Applied Medical Technologies — Product Code KNT

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
May 7, 1993
Date Received
July 23, 1992
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 Applied Medical Technologies

  • K971434 — A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE (August 17, 1998)
  • K972478 — PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES (February 9, 1998)
  • K973893 — AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON M (December 19, 1997)
  • K971757 — LOW PROFILE FEEDING SET ACCESSORY (November 7, 1997)
  • K971758 — CAUTERIZATION SMOKE EVACUATOR (July 21, 1997)
  • K961345 — DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE (September 17, 1996)
  • K960232 — ENDOSCOPIC ACCESS DEVICE (March 21, 1996)
  • K945618 — GASTROINTESTINAL TUBES & ACCESSORIES (October 12, 1995)
  • K946140 — PRG BUTTON (August 28, 1995)
  • K923488 — GASTRANIMAL PERCUTANEOUS REPLACEMENT GASTROOMY (July 20, 1995)

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