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FDA 510(k)

OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM)

K-Number: K870680 · 1987-04-17

Decision Date1987-04-17
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 1987-04-17 under 510(k) number K870680. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM)?

OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM) is a medical device that received FDA 510(k) clearance on 1987-04-17. The listed applicant is Medline Industries, Inc.. The 510(k) number is K870680.

When did OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM) receive FDA 510(k) clearance?

OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM) received FDA 510(k) clearance on 1987-04-17, under 510(k) number K870680.

Who is the listed applicant for OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM)?

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

What is the FDA product code for OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM)?

The FDA product code for OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM) is FET.

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 Medline Industries, 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 223 devices →

Related Devices (Code: FET)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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