
Medicult A/S
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ISM1+, IMS2+, AND UTM+ is an FDA 510(k)-cleared medical device (K030490) manufactured by Medicult A/S. 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 August 19, 2003. Regulation: 8.

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