DeviceClearance

HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)— 510(k) K011113

Substantially Equivalent

Sebia

FDA 510(k) clearance K011113 for HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132), Substantially Equivalent on 2001-06-13. Applicant: Sebia.

Clearance details

Applicant
Sebia
Product code
Code CIN
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chelsea, MI, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.