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FDA 510(k)

OSMED EPI-GUIDE

K-Number: K940643 · 1996-10-15

ApplicantThm Biomedical, Inc.
Decision Date1996-10-15
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSMED EPI-GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Thm Biomedical, Inc.. It received FDA 510(k) clearance on 1996-10-15 under 510(k) number K940643. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSMED EPI-GUIDE?

OSMED EPI-GUIDE is a medical device that received FDA 510(k) clearance on 1996-10-15. The listed applicant is Thm Biomedical, Inc.. The 510(k) number is K940643.

When did OSMED EPI-GUIDE receive FDA 510(k) clearance?

OSMED EPI-GUIDE received FDA 510(k) clearance on 1996-10-15, under 510(k) number K940643.

Who is the listed applicant for OSMED EPI-GUIDE?

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

What is the FDA product code for OSMED EPI-GUIDE?

The FDA product code for OSMED EPI-GUIDE is LYC.

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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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