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FDA 510(k)

ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V

K-Number: K903748 · 1990-10-31

ApplicantDowns Surgical , Ltd.
Decision Date1990-10-31
Product CodeGDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V 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 1990-10-31 under 510(k) number K903748. 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 STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V?

ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V is a medical device that received FDA 510(k) clearance on 1990-10-31. The listed applicant is Downs Surgical , Ltd.. The 510(k) number is K903748.

When did ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V receive FDA 510(k) clearance?

ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V received FDA 510(k) clearance on 1990-10-31, under 510(k) number K903748.

Who is the listed applicant for ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V?

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 STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V?

The FDA product code for ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V 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-UK900609SHEPPERD STRAIGHT AND CURVED NEEDLESK900616SHEPPERD CUTTING FORCEPSK900615SHEPPERD NERVE ROOT RETRACTOR W/SUCTION & FIBRE

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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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