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FDA 510(k)

GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES

K-Number: K002569 · 2000-12-12

ApplicantMalgam Ent., Inc.
Decision Date2000-12-12
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES is the device name listed in this FDA 510(k) record. The listed applicant is Malgam Ent., Inc.. It received FDA 510(k) clearance on 2000-12-12 under 510(k) number K002569. 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 GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES?

GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES is a medical device that received FDA 510(k) clearance on 2000-12-12. The listed applicant is Malgam Ent., Inc.. The 510(k) number is K002569.

When did GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES receive FDA 510(k) clearance?

GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES received FDA 510(k) clearance on 2000-12-12, under 510(k) number K002569.

Who is the listed applicant for GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES?

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

What is the FDA product code for GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES?

The FDA product code for GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES is FMF.

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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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