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FDA 510(k)

ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)

K-Number: K082106 · 2008-10-02

ApplicantElcam Medical Acal
Decision Date2008-10-02
Product CodeFMG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) is the device name listed in this FDA 510(k) record. The listed applicant is Elcam Medical Acal. It received FDA 510(k) clearance on 2008-10-02 under 510(k) number K082106. The device is classified under product code FMG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)?

ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) is a medical device that received FDA 510(k) clearance on 2008-10-02. The listed applicant is Elcam Medical Acal. The 510(k) number is K082106.

When did ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) receive FDA 510(k) clearance?

ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) received FDA 510(k) clearance on 2008-10-02, under 510(k) number K082106.

Who is the listed applicant for ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)?

The FDA 510(k) record lists Elcam Medical Acal as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)?

The FDA product code for ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) is FMG.

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Other records listing Elcam Medical Acal 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.

K231900A-TAP (previously called Arthrotap)K211204SafePort(TM) Manifold (or Stopcock)K190489Elcam Stopcocks and ManifoldsK123084DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLDK120253ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)K120624ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)

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Related Devices (Code: FMG)

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.

K242255Qitexio® 4-Way Stopcock (QIT014)MedexK223499Three Way Stop CockM/S Romsons InternationalK223175lntravascular Administration Sets with Stopcock and ManifoldBaxter Healthcare CorporationK211204SafePort(TM) Manifold (or Stopcock)Elcam Medical AcalK210516Clicky CrossYomura Technologies, Inc.K190539TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non SterileMonumedical, 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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