Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

1,3 & 4 WAY STERILE DIS. PLASTIC PKG.

K-Number: K800862 · 1980-05-30

ApplicantCustom Medical Devices Intl., Inc.
Decision Date1980-05-30
Product CodeFMG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

1,3 & 4 WAY STERILE DIS. PLASTIC PKG. is the device name listed in this FDA 510(k) record. The listed applicant is Custom Medical Devices Intl., Inc.. It received FDA 510(k) clearance on 1980-05-30 under 510(k) number K800862. 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 1,3 & 4 WAY STERILE DIS. PLASTIC PKG.?

1,3 & 4 WAY STERILE DIS. PLASTIC PKG. is a medical device that received FDA 510(k) clearance on 1980-05-30. The listed applicant is Custom Medical Devices Intl., Inc.. The 510(k) number is K800862.

When did 1,3 & 4 WAY STERILE DIS. PLASTIC PKG. receive FDA 510(k) clearance?

1,3 & 4 WAY STERILE DIS. PLASTIC PKG. received FDA 510(k) clearance on 1980-05-30, under 510(k) number K800862.

Who is the listed applicant for 1,3 & 4 WAY STERILE DIS. PLASTIC PKG.?

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

What is the FDA product code for 1,3 & 4 WAY STERILE DIS. PLASTIC PKG.?

The FDA product code for 1,3 & 4 WAY STERILE DIS. PLASTIC PKG. is FMG.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Custom Medical Devices Intl., 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.

K800864STERILE DISPOS. PLASTIC STOPCOCKS W/TUBEK800863TANDEM ASSEMBED 3&4 WAY STERILE STOPCKS

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.

↑