IDENTI LOOPS DEGANIA SILICONE

IDENTI LOOPS DEGANIA SILICONE is an FDA 510(k)-cleared medical device (K920104) manufactured by Puritas Health Care, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 19, 1992. Regulation: 8.