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FDA 510(k)

TANDEM ASSEMBLED 3&4 WAY STOPCOCKS

K-Number: K792124 · 1980-01-16

ApplicantTronomed, Inc.
Decision Date1980-01-16
Product CodeFMG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TANDEM ASSEMBLED 3&4 WAY STOPCOCKS is the device name listed in this FDA 510(k) record. The listed applicant is Tronomed, Inc.. It received FDA 510(k) clearance on 1980-01-16 under 510(k) number K792124. 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 TANDEM ASSEMBLED 3&4 WAY STOPCOCKS?

TANDEM ASSEMBLED 3&4 WAY STOPCOCKS is a medical device that received FDA 510(k) clearance on 1980-01-16. The listed applicant is Tronomed, Inc.. The 510(k) number is K792124.

When did TANDEM ASSEMBLED 3&4 WAY STOPCOCKS receive FDA 510(k) clearance?

TANDEM ASSEMBLED 3&4 WAY STOPCOCKS received FDA 510(k) clearance on 1980-01-16, under 510(k) number K792124.

Who is the listed applicant for TANDEM ASSEMBLED 3&4 WAY STOPCOCKS?

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

What is the FDA product code for TANDEM ASSEMBLED 3&4 WAY STOPCOCKS?

The FDA product code for TANDEM ASSEMBLED 3&4 WAY STOPCOCKS is FMG.

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Other records listing Tronomed, 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.

K952659TRONOMATE PATIENT CABLE & LEADWIRE SYSTEMK853303LIFELINC LEADWIREK853452LIFE LINC PATIENT CABLEK841092HIGH PRESSURE FLEX. CONNECTING TUBINGK792128STERILE EXTENSION TUBES INDIV. PKG.K7921253&4 WAY PLASTIC STOPCOCKS, NONSTERILE

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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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