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FDA 510(k)

THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A

K-Number: K041152 · 2004-05-24

ApplicantApplied Diabetes Research, Inc.
Decision Date2004-05-24
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A is the device name listed in this FDA 510(k) record. The listed applicant is Applied Diabetes Research, Inc.. It received FDA 510(k) clearance on 2004-05-24 under 510(k) number K041152. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A?

THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A is a medical device that received FDA 510(k) clearance on 2004-05-24. The listed applicant is Applied Diabetes Research, Inc.. The 510(k) number is K041152.

When did THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A receive FDA 510(k) clearance?

THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A received FDA 510(k) clearance on 2004-05-24, under 510(k) number K041152.

Who is the listed applicant for THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A?

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

What is the FDA product code for THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A?

The FDA product code for THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A is FRN.

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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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