PYMAH PRE-GAGED BALANCED TEMPA-KUFF

PYMAH PRE-GAGED BALANCED TEMPA-KUFF is an FDA 510(k)-cleared medical device (K903379) manufactured by Pymah Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 18, 1990. Regulation: 8.