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

Clearance record K140088

PHANTOM XL INSULATED DILATORS · Tedan Surgical Innovations, LLC · decided 2014-09-25 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
TSIML-0444STEDAN SURGICAL INNOVATIONS, L.L.C.PDQ00851797006436
TSIML-0441STEDAN SURGICAL INNOVATIONS, L.L.C.PDQ00851797006122
TSIML-0443STEDAN SURGICAL INNOVATIONS, L.L.C.PDQ00851797006139
TSIML-0440STEDAN SURGICAL INNOVATIONS, L.L.C.PDQ00851797006191
TSIML-0449STEDAN SURGICAL INNOVATIONS, L.L.C.PDQ00851797006146