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FDA 510(k)

MALLEABLE PTFE COATED BRAIN SPATULAE

K-Number: K880278 · 1988-02-11

ApplicantDowns Surgical , Ltd.
Decision Date1988-02-11
Product CodeHAO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MALLEABLE PTFE COATED BRAIN SPATULAE 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 1988-02-11 under 510(k) number K880278. The device is classified under product code HAO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MALLEABLE PTFE COATED BRAIN SPATULAE?

MALLEABLE PTFE COATED BRAIN SPATULAE is a medical device that received FDA 510(k) clearance on 1988-02-11. The listed applicant is Downs Surgical , Ltd.. The 510(k) number is K880278.

When did MALLEABLE PTFE COATED BRAIN SPATULAE receive FDA 510(k) clearance?

MALLEABLE PTFE COATED BRAIN SPATULAE received FDA 510(k) clearance on 1988-02-11, under 510(k) number K880278.

Who is the listed applicant for MALLEABLE PTFE COATED BRAIN SPATULAE?

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 MALLEABLE PTFE COATED BRAIN SPATULAE?

The FDA product code for MALLEABLE PTFE COATED BRAIN SPATULAE is HAO.

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Related Devices (Code: HAO)

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.

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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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