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FDA 510(k)

BIOPSY FORCEPS W/OVAL CUP & NEEDLE

K-Number: K820980 · 1982-04-26

ApplicantMill-Rose Laboratory
Decision Date1982-04-26
Product CodeGEN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIOPSY FORCEPS W/OVAL CUP & NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Mill-Rose Laboratory. It received FDA 510(k) clearance on 1982-04-26 under 510(k) number K820980. The device is classified under product code GEN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPSY FORCEPS W/OVAL CUP & NEEDLE?

BIOPSY FORCEPS W/OVAL CUP & NEEDLE is a medical device that received FDA 510(k) clearance on 1982-04-26. The listed applicant is Mill-Rose Laboratory. The 510(k) number is K820980.

When did BIOPSY FORCEPS W/OVAL CUP & NEEDLE receive FDA 510(k) clearance?

BIOPSY FORCEPS W/OVAL CUP & NEEDLE received FDA 510(k) clearance on 1982-04-26, under 510(k) number K820980.

Who is the listed applicant for BIOPSY FORCEPS W/OVAL CUP & NEEDLE?

The FDA 510(k) record lists Mill-Rose Laboratory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOPSY FORCEPS W/OVAL CUP & NEEDLE?

The FDA product code for BIOPSY FORCEPS W/OVAL CUP & NEEDLE is GEN.

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Other records listing Mill-Rose Laboratory 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.

K983122MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KITK983124MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KITK971275MILL-ROSE DISPOSABLE POLYPECTOMY SNAREK962736MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLEK960880MILL-ROSE BLIND MICROBIOLOGY BRUSHK954519WANG TRANSENDOSCOPIC ASPIRATION NEEDLE

View all 46 devices →

Related Devices (Code: GEN)

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.

K031828NATURALASE LP ND:YAG LASERFocus Medical, LLCK953962FORCEPSBiopsys Medical, Inc.K932385SUTURE REMOVING FORCEPSRocket of London, Ltd.K904723FORCEPSMinto Research & Development, Inc.K911159PALPATION PROBENorthgate Technologies, Inc.K900952GS-1200 GRASPING/EXTRACTING FORCEP, 10MMSolos Endoscopy, 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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