
Sumi Salud C.A.
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BKMI DISPOSABLE SYRINGE is an FDA 510(k)-cleared medical device (K971487) manufactured by Sumi Salud C.A.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 3, 1997. Regulation: 8.

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