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)

GP-303

K-Number: K831583 · 1983-07-19

Decision Date1983-07-19
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GP-303 is the device name listed in this FDA 510(k) record. The listed applicant is Hirata Sangyo Co. USA, Inc.. It received FDA 510(k) clearance on 1983-07-19 under 510(k) number K831583. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GP-303?

GP-303 is a medical device that received FDA 510(k) clearance on 1983-07-19. The listed applicant is Hirata Sangyo Co. USA, Inc.. The 510(k) number is K831583.

When did GP-303 receive FDA 510(k) clearance?

GP-303 received FDA 510(k) clearance on 1983-07-19, under 510(k) number K831583.

Who is the listed applicant for GP-303?

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

What is the FDA product code for GP-303?

The FDA product code for GP-303 is DXN.

Other records listing Hirata Sangyo Co. USA, 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.

View all 8 devices →

Related Devices (Code: DXN)

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.

↑