FDA 510(k)

30 ML OR 60 ML PEDI-SYRINGE FILTER

K-Number: K050805 · 2005-06-20

ApplicantBlood Products Specialties, LLC

Decision Date2005-06-20

Product CodeBRZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

30 ML OR 60 ML PEDI-SYRINGE FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Blood Products Specialties, LLC. It received FDA 510(k) clearance on 2005-06-20 under 510(k) number K050805. The device is classified under product code BRZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 30 ML OR 60 ML PEDI-SYRINGE FILTER?

30 ML OR 60 ML PEDI-SYRINGE FILTER is a medical device that received FDA 510(k) clearance on 2005-06-20. The listed applicant is Blood Products Specialties, LLC. The 510(k) number is K050805.

When did 30 ML OR 60 ML PEDI-SYRINGE FILTER receive FDA 510(k) clearance?

30 ML OR 60 ML PEDI-SYRINGE FILTER received FDA 510(k) clearance on 2005-06-20, under 510(k) number K050805.

Who is the listed applicant for 30 ML OR 60 ML PEDI-SYRINGE FILTER?

The FDA 510(k) record lists Blood Products Specialties, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 30 ML OR 60 ML PEDI-SYRINGE FILTER?

The FDA product code for 30 ML OR 60 ML PEDI-SYRINGE FILTER is BRZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.