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FDA 510(k)

OMED FABRIC INSTRUMENT COVERS-RADIOPAQ

K-Number: K821334 · 1982-05-24

ApplicantOmega-Med Intl., Inc.
Decision Date1982-05-24
Product Code
DecisionSubstantially Equivalent

Device Summary

OMED FABRIC INSTRUMENT COVERS-RADIOPAQ is the device name listed in this FDA 510(k) record. The listed applicant is Omega-Med Intl., Inc.. It received FDA 510(k) clearance on 1982-05-24 under 510(k) number K821334. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMED FABRIC INSTRUMENT COVERS-RADIOPAQ?

OMED FABRIC INSTRUMENT COVERS-RADIOPAQ is a medical device that received FDA 510(k) clearance on 1982-05-24. The listed applicant is Omega-Med Intl., Inc.. The 510(k) number is K821334.

When did OMED FABRIC INSTRUMENT COVERS-RADIOPAQ receive FDA 510(k) clearance?

OMED FABRIC INSTRUMENT COVERS-RADIOPAQ received FDA 510(k) clearance on 1982-05-24, under 510(k) number K821334.

Who is the listed applicant for OMED FABRIC INSTRUMENT COVERS-RADIOPAQ?

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

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Other records listing Omega-Med Intl., 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.

K842603OMED DISPOS. INSTRUMENT GUARDSK832441SUTURE-AID BOOTIESK830484OMED IDENT-I-BANDK822284COMPLY NEUROMUSCULAR STIMULATORK813499OMED DISPOSABLE BULLDOGK810883OMED SILICONE INSTRUMENT COVERS

View all 9 devices →

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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