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510(k) K973893

AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE by Applied Medical Technologies — Product Code KNT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 19, 1997
Date Received: October 14, 1997
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)
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)
K923692 — STOMA MEASURING DEVICE (May 7, 1993)

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