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)

PREHEPARINZED SYRINGE

K-Number: K803302 · 1981-04-08

Decision Date1981-04-08
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PREHEPARINZED SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is The University of Chicago. It received FDA 510(k) clearance on 1981-04-08 under 510(k) number K803302. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREHEPARINZED SYRINGE?

PREHEPARINZED SYRINGE is a medical device that received FDA 510(k) clearance on 1981-04-08. The listed applicant is The University of Chicago. The 510(k) number is K803302.

When did PREHEPARINZED SYRINGE receive FDA 510(k) clearance?

PREHEPARINZED SYRINGE received FDA 510(k) clearance on 1981-04-08, under 510(k) number K803302.

Who is the listed applicant for PREHEPARINZED SYRINGE?

The FDA 510(k) record lists The University of Chicago as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREHEPARINZED SYRINGE?

The FDA product code for PREHEPARINZED SYRINGE is FMF.

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.

Other records listing The University of Chicago 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.

Related Devices (Code: FMF)

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.

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.

↑