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FDA 510(k)

600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA

K-Number: K895329 · 1990-10-02

ApplicantDelmed, Inc.
Decision Date1990-10-02
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA is the device name listed in this FDA 510(k) record. The listed applicant is Delmed, Inc.. It received FDA 510(k) clearance on 1990-10-02 under 510(k) number K895329. 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 600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA?

600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA is a medical device that received FDA 510(k) clearance on 1990-10-02. The listed applicant is Delmed, Inc.. The 510(k) number is K895329.

When did 600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA receive FDA 510(k) clearance?

600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA received FDA 510(k) clearance on 1990-10-02, under 510(k) number K895329.

Who is the listed applicant for 600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA?

The FDA 510(k) record lists Delmed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA?

The FDA product code for 600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA is KNT.

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Other records listing Delmed, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K895142ENTERAL PUMP SET WITH ENTERAL SPIKEK895650ENTERAL PUMP SET W/ENTERA-FLO SPIKEK894506ENTERA-FLO ENTERAL FEEDING PUMPK901478DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTIONK901477DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATIONK900106CLOSED DISCONNECT SYSTEM

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Related Devices (Code: KNT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLCK253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)C.R. Bard, Inc.K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,LtdK243228Flexi-Seal AIR (with ENFit Connector)ConvatecK242336hygh-tec Drainage IIAmb MedtecK242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)Tools For Surgery, LLC

Official Source

View on FDA Database →

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

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