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FDA 510(k)

THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS

K-Number: K955282 · 1996-05-06

ApplicantThermogenesis Corp.
Decision Date1996-05-06
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS is the device name listed in this FDA 510(k) record. The listed applicant is Thermogenesis Corp.. It received FDA 510(k) clearance on 1996-05-06 under 510(k) number K955282. 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 THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS?

THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS is a medical device that received FDA 510(k) clearance on 1996-05-06. The listed applicant is Thermogenesis Corp.. The 510(k) number is K955282.

When did THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS receive FDA 510(k) clearance?

THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS received FDA 510(k) clearance on 1996-05-06, under 510(k) number K955282.

Who is the listed applicant for THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS?

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 THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS?

The FDA product code for THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS 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)K071126CRYOSEAL FS APPLICATOR SYSTEM

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

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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