FDA 510(k)

COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12)

K-Number: K991668 · 1999-07-26

Decision Date1999-07-26

Product CodeKNT

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12) is the device name listed in this FDA 510(k) record. The listed applicant is Novartis Nutrition Corp.. It received FDA 510(k) clearance on 1999-07-26 under 510(k) number K991668. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12)?

COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12) is a medical device that received FDA 510(k) clearance on 1999-07-26. The listed applicant is Novartis Nutrition Corp.. The 510(k) number is K991668.

When did COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12) receive FDA 510(k) clearance?

COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12) received FDA 510(k) clearance on 1999-07-26, under 510(k) number K991668.

Who is the listed applicant for COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12)?

The FDA 510(k) record lists Novartis Nutrition Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12)?

The FDA product code for COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12) is KNT.

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Other records listing Novartis Nutrition Corp. as applicant

K080340COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG K071191NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT K001916COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX K981323COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE

Related Devices (Code: KNT)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.