Sebia
HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)
SKU K011113UPC CIN
In Stock
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IIFDA 510(k) Cleared (K011113)
1
Free shipping on orders over $99 · 30-day returns
Sebia
Free shipping on orders over $99 · 30-day returns
HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132) is an FDA 510(k)-cleared medical device (K011113) manufactured by Sebia. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 12, 2001. Regulation: 8.
