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FDA 510(k)

CROSSEAL APPLICATION DEVICE

K-Number: K030032 · 2003-03-21

ApplicantOmrix Biopharmaceuticals, Inc.
Decision Date2003-03-21
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CROSSEAL APPLICATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Omrix Biopharmaceuticals, Inc.. It received FDA 510(k) clearance on 2003-03-21 under 510(k) number K030032. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CROSSEAL APPLICATION DEVICE?

CROSSEAL APPLICATION DEVICE is a medical device that received FDA 510(k) clearance on 2003-03-21. The listed applicant is Omrix Biopharmaceuticals, Inc.. The 510(k) number is K030032.

When did CROSSEAL APPLICATION DEVICE receive FDA 510(k) clearance?

CROSSEAL APPLICATION DEVICE received FDA 510(k) clearance on 2003-03-21, under 510(k) number K030032.

Who is the listed applicant for CROSSEAL APPLICATION DEVICE?

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

What is the FDA product code for CROSSEAL APPLICATION DEVICE?

The FDA product code for CROSSEAL APPLICATION DEVICE is FMI.

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Related Devices (Code: FMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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