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FDA 510(k)

DEXTRANOMER

K-Number: K872117 · 1987-07-24

Decision Date1987-07-24
Product CodeKOZ
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

DEXTRANOMER is the device name listed in this FDA 510(k) record. The listed applicant is Interworld, Inc.. It received FDA 510(k) clearance on 1987-07-24 under 510(k) number K872117. The device is classified under product code KOZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DEXTRANOMER?

DEXTRANOMER is a medical device that received FDA 510(k) clearance on 1987-07-24. The listed applicant is Interworld, Inc.. The 510(k) number is K872117.

When did DEXTRANOMER receive FDA 510(k) clearance?

DEXTRANOMER received FDA 510(k) clearance on 1987-07-24, under 510(k) number K872117.

Who is the listed applicant for DEXTRANOMER?

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

What is the FDA product code for DEXTRANOMER?

The FDA product code for DEXTRANOMER is KOZ.

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.

Related Devices (Code: KOZ)

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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