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)

CODE-A-WELL SERIES 1-600, 1-625

K-Number: K863374 · 1986-09-11

Decision Date1986-09-11
Product CodeJTC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CODE-A-WELL SERIES 1-600, 1-625 is the device name listed in this FDA 510(k) record. The listed applicant is Plastic Injectors, Inc.. It received FDA 510(k) clearance on 1986-09-11 under 510(k) number K863374. The device is classified under product code JTC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CODE-A-WELL SERIES 1-600, 1-625?

CODE-A-WELL SERIES 1-600, 1-625 is a medical device that received FDA 510(k) clearance on 1986-09-11. The listed applicant is Plastic Injectors, Inc.. The 510(k) number is K863374.

When did CODE-A-WELL SERIES 1-600, 1-625 receive FDA 510(k) clearance?

CODE-A-WELL SERIES 1-600, 1-625 received FDA 510(k) clearance on 1986-09-11, under 510(k) number K863374.

Who is the listed applicant for CODE-A-WELL SERIES 1-600, 1-625?

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

What is the FDA product code for CODE-A-WELL SERIES 1-600, 1-625?

The FDA product code for CODE-A-WELL SERIES 1-600, 1-625 is JTC.

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 Plastic Injectors, 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: JTC)

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.

↑