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FDA 510(k)

AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM

K-Number: K042300 · 2004-10-25

ApplicantApplied Medical Technology, Inc.
Decision Date2004-10-25
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Technology, Inc.. It received FDA 510(k) clearance on 2004-10-25 under 510(k) number K042300. 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 AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM?

AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2004-10-25. The listed applicant is Applied Medical Technology, Inc.. The 510(k) number is K042300.

When did AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM receive FDA 510(k) clearance?

AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM received FDA 510(k) clearance on 2004-10-25, under 510(k) number K042300.

Who is the listed applicant for AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM?

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

What is the FDA product code for AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM?

The FDA product code for AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM is KNT.

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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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