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FDA 510(k)

SWEMED NEEDLE GUIDE

K-Number: K925999 · 1994-10-03

ApplicantSwemed Lab Intl.
Decision Date1994-10-03
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SWEMED NEEDLE GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Swemed Lab Intl.. It received FDA 510(k) clearance on 1994-10-03 under 510(k) number K925999. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWEMED NEEDLE GUIDE?

SWEMED NEEDLE GUIDE is a medical device that received FDA 510(k) clearance on 1994-10-03. The listed applicant is Swemed Lab Intl.. The 510(k) number is K925999.

When did SWEMED NEEDLE GUIDE receive FDA 510(k) clearance?

SWEMED NEEDLE GUIDE received FDA 510(k) clearance on 1994-10-03, under 510(k) number K925999.

Who is the listed applicant for SWEMED NEEDLE GUIDE?

The FDA 510(k) record lists Swemed Lab Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SWEMED NEEDLE GUIDE?

The FDA product code for SWEMED NEEDLE GUIDE is IYO.

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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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