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FDA 510(k)

ISLAM BONE MARROW BIOPSY NEEDLE

K-Number: K820339 · 1982-02-23

ApplicantDowns Surgical , Ltd.
Decision Date1982-02-23
Product CodeGDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ISLAM BONE MARROW BIOPSY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Downs Surgical , Ltd.. It received FDA 510(k) clearance on 1982-02-23 under 510(k) number K820339. The device is classified under product code GDM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISLAM BONE MARROW BIOPSY NEEDLE?

ISLAM BONE MARROW BIOPSY NEEDLE is a medical device that received FDA 510(k) clearance on 1982-02-23. The listed applicant is Downs Surgical , Ltd.. The 510(k) number is K820339.

When did ISLAM BONE MARROW BIOPSY NEEDLE receive FDA 510(k) clearance?

ISLAM BONE MARROW BIOPSY NEEDLE received FDA 510(k) clearance on 1982-02-23, under 510(k) number K820339.

Who is the listed applicant for ISLAM BONE MARROW BIOPSY NEEDLE?

The FDA 510(k) record lists Downs Surgical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISLAM BONE MARROW BIOPSY NEEDLE?

The FDA product code for ISLAM BONE MARROW BIOPSY NEEDLE is GDM.

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Other records listing Downs Surgical , Ltd. 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.

K903750ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-EK903747ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-UK903749ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-UK903748ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-VK900609SHEPPERD STRAIGHT AND CURVED NEEDLESK900616SHEPPERD CUTTING FORCEPS

View all 60 devices →

Related Devices (Code: GDM)

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.

K071732MARROWMINERStemcor Systems, Inc.K971114BIOACCESS MARROW HARVEST SYSTEMBioaccess, Inc.K953082ILIAC CREST BONE MARROW ASPIRATION NEEDLEBaxter Healthcare CorpK953064BIOACCESS MARROW HARVEST SYSTEMBioaccess, Inc.K936207ENDO-NEEDLE INSTRUMENTGerard Medical, Inc.K930160ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLESymbiosis 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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