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FDA 510(k)

CTA MEDIUM TUBE

K-Number: K834425 · 1984-01-17

Decision Date1984-01-17
Product CodeJSG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CTA MEDIUM TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Otisville Biotech, Inc.. It received FDA 510(k) clearance on 1984-01-17 under 510(k) number K834425. The device is classified under product code JSG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CTA MEDIUM TUBE?

CTA MEDIUM TUBE is a medical device that received FDA 510(k) clearance on 1984-01-17. The listed applicant is Otisville Biotech, Inc.. The 510(k) number is K834425.

When did CTA MEDIUM TUBE receive FDA 510(k) clearance?

CTA MEDIUM TUBE received FDA 510(k) clearance on 1984-01-17, under 510(k) number K834425.

Who is the listed applicant for CTA MEDIUM TUBE?

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

What is the FDA product code for CTA MEDIUM TUBE?

The FDA product code for CTA MEDIUM TUBE is JSG.

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 Otisville Biotech, 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 98 devices →

Related Devices (Code: JSG)

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.

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