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FDA 510(k)

TERUMO U-100 INSULIN SYRINGE

K-Number: K992802 · 1999-09-09

ApplicantTerumo Medical Corp.
Decision Date1999-09-09
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TERUMO U-100 INSULIN SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 1999-09-09 under 510(k) number K992802. 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 TERUMO U-100 INSULIN SYRINGE?

TERUMO U-100 INSULIN SYRINGE is a medical device that received FDA 510(k) clearance on 1999-09-09. The listed applicant is Terumo Medical Corp.. The 510(k) number is K992802.

When did TERUMO U-100 INSULIN SYRINGE receive FDA 510(k) clearance?

TERUMO U-100 INSULIN SYRINGE received FDA 510(k) clearance on 1999-09-09, under 510(k) number K992802.

Who is the listed applicant for TERUMO U-100 INSULIN SYRINGE?

The FDA 510(k) record lists Terumo Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TERUMO U-100 INSULIN SYRINGE?

The FDA product code for TERUMO U-100 INSULIN SYRINGE is FMF.

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Other records listing Terumo Medical Corp. as applicant

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Related Devices (Code: 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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