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FDA 510(k)

ABG NEEDLE PROTECTION

K-Number: K945485 · 1994-11-29

ApplicantDevon Industries, Inc.
Decision Date1994-11-29
Product CodeCBT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ABG NEEDLE PROTECTION is the device name listed in this FDA 510(k) record. The listed applicant is Devon Industries, Inc.. It received FDA 510(k) clearance on 1994-11-29 under 510(k) number K945485. 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 ABG NEEDLE PROTECTION?

ABG NEEDLE PROTECTION is a medical device that received FDA 510(k) clearance on 1994-11-29. The listed applicant is Devon Industries, Inc.. The 510(k) number is K945485.

When did ABG NEEDLE PROTECTION receive FDA 510(k) clearance?

ABG NEEDLE PROTECTION received FDA 510(k) clearance on 1994-11-29, under 510(k) number K945485.

Who is the listed applicant for ABG NEEDLE PROTECTION?

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

What is the FDA product code for ABG NEEDLE PROTECTION?

The FDA product code for ABG NEEDLE PROTECTION is CBT.

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Other records listing Devon Industries, 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.

K961993BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)K954015ABG POINT LOK NEEDLE PROTECTION DEVICEK946289DEVONS POINT LOK NEEDLE PROTECTION DEVICEK943892POINT OF USE SHARPS A GATORK944114PHLEBOTOMY UNIT SHARPS A GATORK945197THE SHARPS COLLECTION AND DISPOSAL SYSTEM

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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.K950098NEEDLE SAFETY COVERHammer-Plane, 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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