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FDA 510(k)

PROSAFE SAFETY SYRINGE

K-Number: K012726 · 2001-10-18

ApplicantHou-Se Medical, Inc.
Decision Date2001-10-18
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROSAFE SAFETY SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Hou-Se Medical, Inc.. It received FDA 510(k) clearance on 2001-10-18 under 510(k) number K012726. 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 PROSAFE SAFETY SYRINGE?

PROSAFE SAFETY SYRINGE is a medical device that received FDA 510(k) clearance on 2001-10-18. The listed applicant is Hou-Se Medical, Inc.. The 510(k) number is K012726.

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

PROSAFE SAFETY SYRINGE received FDA 510(k) clearance on 2001-10-18, under 510(k) number K012726.

Who is the listed applicant for PROSAFE SAFETY SYRINGE?

The FDA 510(k) record lists Hou-Se Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROSAFE SAFETY SYRINGE?

The FDA product code for PROSAFE 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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