
The Altomec Corp.
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ETB TELESCOPE W/WORKING CHANNEL FOR SEPS is an FDA 510(k)-cleared medical device (K972298) manufactured by The Altomec Corp.. 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 January 29, 1998. Regulation: 8.