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FDA 510(k)

NEEDLE SAFETY COVER

K-Number: K950098 · 1995-08-11

ApplicantHammer-Plane, Inc.
Decision Date1995-08-11
Product CodeCBT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEEDLE SAFETY COVER is the device name listed in this FDA 510(k) record. The listed applicant is Hammer-Plane, Inc.. It received FDA 510(k) clearance on 1995-08-11 under 510(k) number K950098. The device is classified under product code CBT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEEDLE SAFETY COVER?

NEEDLE SAFETY COVER is a medical device that received FDA 510(k) clearance on 1995-08-11. The listed applicant is Hammer-Plane, Inc.. The 510(k) number is K950098.

When did NEEDLE SAFETY COVER receive FDA 510(k) clearance?

NEEDLE SAFETY COVER received FDA 510(k) clearance on 1995-08-11, under 510(k) number K950098.

Who is the listed applicant for NEEDLE SAFETY COVER?

The FDA 510(k) record lists Hammer-Plane, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEEDLE SAFETY COVER?

The FDA product code for NEEDLE SAFETY COVER is CBT.

Related Clinical Trials

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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Other records listing Hammer-Plane, Inc. 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.

K933781ANTI-DISCONNECTION MECHANISM

Related Devices (Code: CBT)

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.

K071269HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEMSmiths Medical Asd, Inc.K070340SECURE ARTERIAL BLOOD SAMPLING SYSTEMSmiths Medical Asd, Inc.K955663ABC IN-LINE BLOOD SAMPLING KITUtah Medical Products, Inc.K954015ABG POINT LOK NEEDLE PROTECTION DEVICEDevon Industries, Inc.K954035ACTI-FLEX ARTERIAL EXTENSION SETR-Group Intl.K945719ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEMSherwood Medical Co.

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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