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FDA 510(k)

DAUM BONE BIOPSY SET

K-Number: K981320 · 1998-06-29

ApplicantDaum Corp.
Decision Date1998-06-29
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DAUM BONE BIOPSY SET is the device name listed in this FDA 510(k) record. The listed applicant is Daum Corp.. It received FDA 510(k) clearance on 1998-06-29 under 510(k) number K981320. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DAUM BONE BIOPSY SET?

DAUM BONE BIOPSY SET is a medical device that received FDA 510(k) clearance on 1998-06-29. The listed applicant is Daum Corp.. The 510(k) number is K981320.

When did DAUM BONE BIOPSY SET receive FDA 510(k) clearance?

DAUM BONE BIOPSY SET received FDA 510(k) clearance on 1998-06-29, under 510(k) number K981320.

Who is the listed applicant for DAUM BONE BIOPSY SET?

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

What is the FDA product code for DAUM BONE BIOPSY SET?

The FDA product code for DAUM BONE BIOPSY SET is KNW.

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Other records listing Daum Corp. 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.

K990278DAUM NEUROCUT NEUROBIOPSYNEEDLEK974631DAUM NEUROBIOPSY NEEDLEK974575DAUM ASPIRATIONBIOPSY NEEDLEK974574DAUM NEUROPUNCTURE NEEDLEK974576DAUM BIOPSYGUN

Related Devices (Code: KNW)

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.

K260517Automatic Core Biopsy InstrumentZhejiang Curaway Medical Technology Co., Ltd.K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc.K260572Marrow MarxmanMedimetrix, LLCK261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd.K260365Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery CharDevicor Medical Products, Inc.

Official Source

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