
Pos-T-Vac, Inc.
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POS-T-VAC (REJOYN VACUUM ERECTION DEVICE) is an FDA 510(k)-cleared medical device (K981011) manufactured by Pos-T-Vac, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 27, 1998. Regulation: 8.