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FDA 510(k)

SYNTHEMED DEVICE

K-Number: K082276 · 2008-11-18

ApplicantSynthemed, Inc.
Decision Date2008-11-18
Product CodeLYA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SYNTHEMED DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Synthemed, Inc.. It received FDA 510(k) clearance on 2008-11-18 under 510(k) number K082276. The device is classified under product code LYA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHEMED DEVICE?

SYNTHEMED DEVICE is a medical device that received FDA 510(k) clearance on 2008-11-18. The listed applicant is Synthemed, Inc.. The 510(k) number is K082276.

When did SYNTHEMED DEVICE receive FDA 510(k) clearance?

SYNTHEMED DEVICE received FDA 510(k) clearance on 2008-11-18, under 510(k) number K082276.

Who is the listed applicant for SYNTHEMED DEVICE?

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

What is the FDA product code for SYNTHEMED DEVICE?

The FDA product code for SYNTHEMED DEVICE is LYA.

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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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