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FDA 510(k)

RECAP-1

K-Number: K960641 · 1996-05-17

ApplicantMedscience, Inc.
Decision Date1996-05-17
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RECAP-1 is the device name listed in this FDA 510(k) record. The listed applicant is Medscience, Inc.. It received FDA 510(k) clearance on 1996-05-17 under 510(k) number K960641. 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 RECAP-1?

RECAP-1 is a medical device that received FDA 510(k) clearance on 1996-05-17. The listed applicant is Medscience, Inc.. The 510(k) number is K960641.

When did RECAP-1 receive FDA 510(k) clearance?

RECAP-1 received FDA 510(k) clearance on 1996-05-17, under 510(k) number K960641.

Who is the listed applicant for RECAP-1?

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

What is the FDA product code for RECAP-1?

The FDA product code for RECAP-1 is FMI.

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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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