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FDA 510(k)

SAFE-T-CAP

K-Number: K895432 · 1989-11-03

ApplicantAusmedics Pty , Ltd.
Decision Date1989-11-03
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAFE-T-CAP is the device name listed in this FDA 510(k) record. The listed applicant is Ausmedics Pty , Ltd.. It received FDA 510(k) clearance on 1989-11-03 under 510(k) number K895432. 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 SAFE-T-CAP?

SAFE-T-CAP is a medical device that received FDA 510(k) clearance on 1989-11-03. The listed applicant is Ausmedics Pty , Ltd.. The 510(k) number is K895432.

When did SAFE-T-CAP receive FDA 510(k) clearance?

SAFE-T-CAP received FDA 510(k) clearance on 1989-11-03, under 510(k) number K895432.

Who is the listed applicant for SAFE-T-CAP?

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

What is the FDA product code for SAFE-T-CAP?

The FDA product code for SAFE-T-CAP is FMI.

Other records listing Ausmedics Pty , Ltd. 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.

K896219SAFE-T-CAP NEEDLE COVER

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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