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FDA 510(k)

DISPOSABLE NEEDLE HOLDERS

K-Number: K821618 · 1982-06-21

ApplicantMedcare Products
Decision Date1982-06-21
Product CodeFZX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE NEEDLE HOLDERS is the device name listed in this FDA 510(k) record. The listed applicant is Medcare Products. It received FDA 510(k) clearance on 1982-06-21 under 510(k) number K821618. The device is classified under product code FZX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE NEEDLE HOLDERS?

DISPOSABLE NEEDLE HOLDERS is a medical device that received FDA 510(k) clearance on 1982-06-21. The listed applicant is Medcare Products. The 510(k) number is K821618.

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

DISPOSABLE NEEDLE HOLDERS received FDA 510(k) clearance on 1982-06-21, under 510(k) number K821618.

Who is the listed applicant for DISPOSABLE NEEDLE HOLDERS?

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 HOLDERS?

The FDA product code for DISPOSABLE NEEDLE HOLDERS is FZX.

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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

View all 20 devices →

Related Devices (Code: FZX)

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.

K914715PARALLELING GUIDESImplant Corp. of AmericaK871413CIVCO STEPPERCIVCO Medical Instruments Co., Inc.K871503BIOPSY NEEDLE GUIDE KIT, STERILEAmedic USAK862564A.C.L. GUIDE KITAspen Laboratories, Inc.K854262MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLYMeadox Surgimed, Inc.K852402NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZERNorth American Instrument Corp.

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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