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FDA 510(k)

E.N.S.I. RETRACTABLE SAFETY SYRINGE

K-Number: K003348 · 2001-01-12

ApplicantEnsi-Med International Pty. , Ltd.
Decision Date2001-01-12
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

E.N.S.I. RETRACTABLE SAFETY SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Ensi-Med International Pty. , Ltd.. It received FDA 510(k) clearance on 2001-01-12 under 510(k) number K003348. 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 E.N.S.I. RETRACTABLE SAFETY SYRINGE?

E.N.S.I. RETRACTABLE SAFETY SYRINGE is a medical device that received FDA 510(k) clearance on 2001-01-12. The listed applicant is Ensi-Med International Pty. , Ltd.. The 510(k) number is K003348.

When did E.N.S.I. RETRACTABLE SAFETY SYRINGE receive FDA 510(k) clearance?

E.N.S.I. RETRACTABLE SAFETY SYRINGE received FDA 510(k) clearance on 2001-01-12, under 510(k) number K003348.

Who is the listed applicant for E.N.S.I. RETRACTABLE SAFETY SYRINGE?

The FDA 510(k) record lists Ensi-Med International Pty. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E.N.S.I. RETRACTABLE SAFETY SYRINGE?

The FDA product code for E.N.S.I. RETRACTABLE 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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