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FDA 510(k)

DISPOSABLE NEEDLE HOLDER

K-Number: K831665 · 1983-09-12

ApplicantMedcare Products
Decision Date1983-09-12
Product CodeKDC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE NEEDLE HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Medcare Products. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K831665. 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 DISPOSABLE NEEDLE HOLDER?

DISPOSABLE NEEDLE HOLDER is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Medcare Products. The 510(k) number is K831665.

When did DISPOSABLE NEEDLE HOLDER receive FDA 510(k) clearance?

DISPOSABLE NEEDLE HOLDER received FDA 510(k) clearance on 1983-09-12, under 510(k) number K831665.

Who is the listed applicant for DISPOSABLE NEEDLE HOLDER?

The FDA 510(k) record lists Medcare Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE NEEDLE HOLDER?

The FDA product code for DISPOSABLE NEEDLE HOLDER is KDC.

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.

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Other records listing Medcare Products 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.

K841122TRACHEOSTOMY CARE TRAYK841124DIALYSIS TRAYK841123DRESSING CHANGE TRAYK831374MED CARE PREP RAZORK831663TISSUE FORCEPSK831664PLASTIC THUMB FORCEPS

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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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