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FDA 510(k)

CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray

K-Number: K172203 · 2017-10-18

ApplicantNuance Medical, LLC
Decision Date2017-10-18
Product CodeMLY
DecisionSubstantially Equivalent

Device Summary

CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray is a medical device manufactured by Nuance Medical, LLC. It received FDA 510(k) clearance on 2017-10-18 under approval number K172203. The device is classified under product code MLY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray?

CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray is a medical device that received FDA 510(k) clearance on 2017-10-18. It is manufactured by Nuance Medical, LLC. The 510(k) number is K172203.

When was CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray approved by the FDA?

CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray received FDA 510(k) clearance on 2017-10-18, under approval number K172203.

What company makes CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray?

CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray is manufactured by Nuance Medical, LLC.

What is the FDA product code for CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray?

The FDA product code for CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray is MLY.

Other Devices by Nuance Medical, LLC

K162218Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 K161337CryoDose H or Similar K210310CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit K232674PainFreeze II

Related Devices (Code: MLY)

K162218Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102Nuance Medical, LLC K172028Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)Gebauer Company K172598Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREEItw Contamination Control Electronics K190161Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine SprayGebauer Company K202782num Vapocoolant623 Medical, LLC K201248Syringe Holder accessoryVapocoolshot, Inc.

Official Source

View on FDA Database →

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

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