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

Clearance record K211330

R3 Large Head Liners · Smith & Nephew, Inc. · decided 2022-01-19 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
R371935848Smith & Nephew, Inc.LPH00885556776124
R371935847Smith & Nephew, Inc.LPH00885556776117
R371935850Smith & Nephew, Inc.LPH00885556776148
R371935851Smith & Nephew, Inc.LPH00885556776155
R371935849Smith & Nephew, Inc.LPH00885556776131
R371935846Smith & Nephew, Inc.LPH00885556776100