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FDA 510(k)

OMED DISPOSABLE BULLDOG

K-Number: K813499 · 1981-12-29

ApplicantOmega-Med Intl., Inc.
Decision Date1981-12-29
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OMED DISPOSABLE BULLDOG 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 1981-12-29 under 510(k) number K813499. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMED DISPOSABLE BULLDOG?

OMED DISPOSABLE BULLDOG is a medical device that received FDA 510(k) clearance on 1981-12-29. The listed applicant is Omega-Med Intl., Inc.. The 510(k) number is K813499.

When did OMED DISPOSABLE BULLDOG receive FDA 510(k) clearance?

OMED DISPOSABLE BULLDOG received FDA 510(k) clearance on 1981-12-29, under 510(k) number K813499.

Who is the listed applicant for OMED DISPOSABLE BULLDOG?

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

What is the FDA product code for OMED DISPOSABLE BULLDOG?

The FDA product code for OMED DISPOSABLE BULLDOG is DXC.

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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 STIMULATORK821334OMED FABRIC INSTRUMENT COVERS-RADIOPAQK810883OMED SILICONE INSTRUMENT COVERS

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Related Devices (Code: DXC)

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.

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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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