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FDA 510(k)

INJEKT SYRINGE

K-Number: K063280 · 2006-11-17

ApplicantB.Braun Medical, Inc.
Decision Date2006-11-17
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INJEKT SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2006-11-17 under 510(k) number K063280. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INJEKT SYRINGE?

INJEKT SYRINGE is a medical device that received FDA 510(k) clearance on 2006-11-17. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K063280.

When did INJEKT SYRINGE receive FDA 510(k) clearance?

INJEKT SYRINGE received FDA 510(k) clearance on 2006-11-17, under 510(k) number K063280.

Who is the listed applicant for INJEKT SYRINGE?

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

What is the FDA product code for INJEKT SYRINGE?

The FDA product code for INJEKT SYRINGE is FMF.

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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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