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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K193556

Cryocheck Hex LA · Precision Biologic · decided 2020-10-23 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
CRYOcheck Hex LAHex LA-7Precision Biologic IncGFO00843876000527
CRYOcheck Hex LA Hex LAPrecision Biologic IncGFO00843876000510
CRYOcheck Hex LAHEXLA-MPrecision Biologic IncGFO00843876000596