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FDA 510(k)

CRYOSEAL FS APPLICATOR SYSTEM

K-Number: K071126 · 2007-08-16

ApplicantThermogenesis Corp.
Decision Date2007-08-16
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CRYOSEAL FS APPLICATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Thermogenesis Corp.. It received FDA 510(k) clearance on 2007-08-16 under 510(k) number K071126. 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 CRYOSEAL FS APPLICATOR SYSTEM?

CRYOSEAL FS APPLICATOR SYSTEM is a medical device that received FDA 510(k) clearance on 2007-08-16. The listed applicant is Thermogenesis Corp.. The 510(k) number is K071126.

When did CRYOSEAL FS APPLICATOR SYSTEM receive FDA 510(k) clearance?

CRYOSEAL FS APPLICATOR SYSTEM received FDA 510(k) clearance on 2007-08-16, under 510(k) number K071126.

Who is the listed applicant for CRYOSEAL FS APPLICATOR SYSTEM?

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

What is the FDA product code for CRYOSEAL FS APPLICATOR SYSTEM?

The FDA product code for CRYOSEAL FS APPLICATOR SYSTEM is FMF.

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Other records listing Thermogenesis Corp. as applicant

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.

K081345AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)K955282THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS

Related Devices (Code: FMF)

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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