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FDA 510(k)

OTTER SAFETY SYRINGE

K-Number: K040545 · 2004-04-22

ApplicantOtter (China) Technology Co., Ltd.
Decision Date2004-04-22
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OTTER SAFETY SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Otter (China) Technology Co., Ltd.. It received FDA 510(k) clearance on 2004-04-22 under 510(k) number K040545. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTTER SAFETY SYRINGE?

OTTER SAFETY SYRINGE is a medical device that received FDA 510(k) clearance on 2004-04-22. The listed applicant is Otter (China) Technology Co., Ltd.. The 510(k) number is K040545.

When did OTTER SAFETY SYRINGE receive FDA 510(k) clearance?

OTTER SAFETY SYRINGE received FDA 510(k) clearance on 2004-04-22, under 510(k) number K040545.

Who is the listed applicant for OTTER SAFETY SYRINGE?

The FDA 510(k) record lists Otter (China) Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OTTER SAFETY SYRINGE?

The FDA product code for OTTER SAFETY SYRINGE is MEG.

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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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