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FDA 510(k)

INNOVASA STAT*SEAL TOPICAL HEMOSTAT

K-Number: K071225 · 2007-08-31

Decision Date2007-08-31
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INNOVASA STAT*SEAL TOPICAL HEMOSTAT is the device name listed in this FDA 510(k) record. The listed applicant is Innovasa, Inc.. It received FDA 510(k) clearance on 2007-08-31 under 510(k) number K071225. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOVASA STAT*SEAL TOPICAL HEMOSTAT?

INNOVASA STAT*SEAL TOPICAL HEMOSTAT is a medical device that received FDA 510(k) clearance on 2007-08-31. The listed applicant is Innovasa, Inc.. The 510(k) number is K071225.

When did INNOVASA STAT*SEAL TOPICAL HEMOSTAT receive FDA 510(k) clearance?

INNOVASA STAT*SEAL TOPICAL HEMOSTAT received FDA 510(k) clearance on 2007-08-31, under 510(k) number K071225.

Who is the listed applicant for INNOVASA STAT*SEAL TOPICAL HEMOSTAT?

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

What is the FDA product code for INNOVASA STAT*SEAL TOPICAL HEMOSTAT?

The FDA product code for INNOVASA STAT*SEAL TOPICAL HEMOSTAT is DXC.

Related Clinical Trials

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.

Related Devices (Code: DXC)

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.

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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