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FDA 510(k)

OBUS FORME ORTHOPEDIC BRACE, UPRIGHT

K-Number: K820051 · 1982-01-29

Decision Date1982-01-29
Product CodeIQE
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

OBUS FORME ORTHOPEDIC BRACE, UPRIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Obus Forme, Ltd.. It received FDA 510(k) clearance on 1982-01-29 under 510(k) number K820051. The device is classified under product code IQE. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OBUS FORME ORTHOPEDIC BRACE, UPRIGHT?

OBUS FORME ORTHOPEDIC BRACE, UPRIGHT is a medical device that received FDA 510(k) clearance on 1982-01-29. The listed applicant is Obus Forme, Ltd.. The 510(k) number is K820051.

When did OBUS FORME ORTHOPEDIC BRACE, UPRIGHT receive FDA 510(k) clearance?

OBUS FORME ORTHOPEDIC BRACE, UPRIGHT received FDA 510(k) clearance on 1982-01-29, under 510(k) number K820051.

Who is the listed applicant for OBUS FORME ORTHOPEDIC BRACE, UPRIGHT?

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

What is the FDA product code for OBUS FORME ORTHOPEDIC BRACE, UPRIGHT?

The FDA product code for OBUS FORME ORTHOPEDIC BRACE, UPRIGHT is IQE.

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: IQE)

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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