
Graphic Controls Corp.
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GARDOSI BIRTHING CUSHION is an FDA 510(k)-cleared medical device (K903973) manufactured by Graphic Controls Corp.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 26, 1990. Regulation: 8.

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