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FDA 510(k)

PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01

K-Number: K001098 · 2000-05-18

ApplicantPro. Duct Health, Inc.
Decision Date2000-05-18
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01 is the device name listed in this FDA 510(k) record. The listed applicant is Pro. Duct Health, Inc.. It received FDA 510(k) clearance on 2000-05-18 under 510(k) number K001098. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01?

PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01 is a medical device that received FDA 510(k) clearance on 2000-05-18. The listed applicant is Pro. Duct Health, Inc.. The 510(k) number is K001098.

When did PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01 receive FDA 510(k) clearance?

PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01 received FDA 510(k) clearance on 2000-05-18, under 510(k) number K001098.

Who is the listed applicant for PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01?

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

What is the FDA product code for PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01?

The FDA product code for PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01 is FMI.

Related Clinical Trials

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Other records listing Pro. Duct Health, 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.

K000135PRO.DUCT CATHETER, MODEL CTH03

Related Devices (Code: FMI)

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.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

Official Source

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