P-1 (PREIMPLANTATION STAGE ONE) MEDIUM

P-1 (PREIMPLANTATION STAGE ONE) MEDIUM is an FDA 510(k)-cleared medical device (K983589) manufactured by Irvine Scientific Sales Co., Inc.. 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 February 17, 1999. Regulation: 8.