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FDA 510(k)

OMED SILICONE INSTRUMENT COVERS

K-Number: K810883 · 1981-04-23

ApplicantOmega-Med Intl., Inc.
Decision Date1981-04-23
Product CodeKDC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OMED SILICONE INSTRUMENT COVERS 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 1981-04-23 under 510(k) number K810883. The device is classified under product code KDC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMED SILICONE INSTRUMENT COVERS?

OMED SILICONE INSTRUMENT COVERS is a medical device that received FDA 510(k) clearance on 1981-04-23. The listed applicant is Omega-Med Intl., Inc.. The 510(k) number is K810883.

When did OMED SILICONE INSTRUMENT COVERS receive FDA 510(k) clearance?

OMED SILICONE INSTRUMENT COVERS received FDA 510(k) clearance on 1981-04-23, under 510(k) number K810883.

Who is the listed applicant for OMED SILICONE INSTRUMENT COVERS?

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 SILICONE INSTRUMENT COVERS?

The FDA product code for OMED SILICONE INSTRUMENT COVERS is KDC.

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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-RADIOPAQK813499OMED DISPOSABLE BULLDOG

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Related Devices (Code: KDC)

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.

K943229DISPOSABLE SURGICAL SCISSORS AND FORCEPSY.M.K. International Co., Ltd.K936226SURGIMED BREAST LOCALIZATION NEEDLE WIRE SETMeadox Medicals, Div. Boston Scientific Corp.K920153THERMUFF BAGTechstylesK920263MANUAL SURGICAL INSTRUMENTSPhoenix Instruments Div.K915064DISPOSABLE CAUTERY ABRASIVE PADAmerican Medical Mfg., Inc.K914960INSTRUMENT ORGANIZERO.R. Concepts, Inc.

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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