PARACERVICAL/PUDENDAL TRAYS

PARACERVICAL/PUDENDAL TRAYS is an FDA 510(k)-cleared medical device (K896799) manufactured by Westmark, Sterile Packing Systems, Inc. (Sps). This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 22, 1990. Regulation: 8.