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FDA 510(k)

EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT)

K-Number: K050495 · 2005-05-02

ApplicantBaxter Healthcare Corp., Bioscience
Decision Date2005-05-02
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT) is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp., Bioscience. It received FDA 510(k) clearance on 2005-05-02 under 510(k) number K050495. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT)?

EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT) is a medical device that received FDA 510(k) clearance on 2005-05-02. The listed applicant is Baxter Healthcare Corp., Bioscience. The 510(k) number is K050495.

When did EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT) receive FDA 510(k) clearance?

EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT) received FDA 510(k) clearance on 2005-05-02, under 510(k) number K050495.

Who is the listed applicant for EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT)?

The FDA 510(k) record lists Baxter Healthcare Corp., Bioscience as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT)?

The FDA product code for EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT) is FMF.

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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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