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FDA 510(k)

PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES

K-Number: K002381 · 2001-01-11

ApplicantPentaferte, S.R.L.
Decision Date2001-01-11
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES is the device name listed in this FDA 510(k) record. The listed applicant is Pentaferte, S.R.L.. It received FDA 510(k) clearance on 2001-01-11 under 510(k) number K002381. 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 PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES?

PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES is a medical device that received FDA 510(k) clearance on 2001-01-11. The listed applicant is Pentaferte, S.R.L.. The 510(k) number is K002381.

When did PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES receive FDA 510(k) clearance?

PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES received FDA 510(k) clearance on 2001-01-11, under 510(k) number K002381.

Who is the listed applicant for PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES?

The FDA 510(k) record lists Pentaferte, S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES?

The FDA product code for PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES is FMF.

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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

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

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