
Sola Medical Devices, LLC
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SOLA, COUNTER-PULSATION, MODEL SECP-S is an FDA 510(k)-cleared medical device (K022078) manufactured by Sola Medical Devices, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 9, 2003. Regulation: 8.