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FDA 510(k)

Cryocheck Hex LA

K-Number: K193556 · 2020-10-23

Decision Date2020-10-23
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Cryocheck Hex LA is a medical device manufactured by Precision Biologic. It received FDA 510(k) clearance on 2020-10-23 under approval number K193556. The device is classified under product code GFO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cryocheck Hex LA?

Cryocheck Hex LA is a medical device that received FDA 510(k) clearance on 2020-10-23. It is manufactured by Precision Biologic. The 510(k) number is K193556.

When was Cryocheck Hex LA approved by the FDA?

Cryocheck Hex LA received FDA 510(k) clearance on 2020-10-23, under approval number K193556.

What company makes Cryocheck Hex LA?

Cryocheck Hex LA is manufactured by Precision Biologic.

What is the FDA product code for Cryocheck Hex LA?

The FDA product code for Cryocheck Hex LA is GFO.

Other Devices by Precision Biologic

Related Devices (Code: GFO)

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.