
Qualis, Inc.
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PERSONAL WARMING JELLY is an FDA 510(k)-cleared medical device (K050212) manufactured by Qualis, Inc.. 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 March 16, 2005. Regulation: 8.

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