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FDA 510(k)

SUTURE-AID BOOTIES

K-Number: K832441 · 1984-03-05

ApplicantOmega-Med Intl., Inc.
Decision Date1984-03-05
Product CodeKDC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUTURE-AID BOOTIES 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 1984-03-05 under 510(k) number K832441. 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 SUTURE-AID BOOTIES?

SUTURE-AID BOOTIES is a medical device that received FDA 510(k) clearance on 1984-03-05. The listed applicant is Omega-Med Intl., Inc.. The 510(k) number is K832441.

When did SUTURE-AID BOOTIES receive FDA 510(k) clearance?

SUTURE-AID BOOTIES received FDA 510(k) clearance on 1984-03-05, under 510(k) number K832441.

Who is the listed applicant for SUTURE-AID BOOTIES?

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 SUTURE-AID BOOTIES?

The FDA product code for SUTURE-AID BOOTIES 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 GUARDSK830484OMED IDENT-I-BANDK822284COMPLY NEUROMUSCULAR STIMULATORK821334OMED FABRIC INSTRUMENT COVERS-RADIOPAQK813499OMED DISPOSABLE BULLDOGK810883OMED SILICONE INSTRUMENT COVERS

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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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