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FDA 510(k)

SAFE-SITE NEEDLE COVER

K-Number: K905305 · 1991-02-12

ApplicantNorth American Medical Products, Inc.
Decision Date1991-02-12
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAFE-SITE NEEDLE COVER is the device name listed in this FDA 510(k) record. The listed applicant is North American Medical Products, Inc.. It received FDA 510(k) clearance on 1991-02-12 under 510(k) number K905305. 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-SITE NEEDLE COVER?

SAFE-SITE NEEDLE COVER is a medical device that received FDA 510(k) clearance on 1991-02-12. The listed applicant is North American Medical Products, Inc.. The 510(k) number is K905305.

When did SAFE-SITE NEEDLE COVER receive FDA 510(k) clearance?

SAFE-SITE NEEDLE COVER received FDA 510(k) clearance on 1991-02-12, under 510(k) number K905305.

Who is the listed applicant for SAFE-SITE NEEDLE COVER?

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

What is the FDA product code for SAFE-SITE NEEDLE COVER?

The FDA product code for SAFE-SITE NEEDLE COVER is FMI.

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Other records listing North American Medical Products, Inc. as applicant

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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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