
Eimark Labs, Inc.
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BENDEREV PROTECT-A-PASS NEEDLE is an FDA 510(k)-cleared medical device (K921228) manufactured by Eimark Labs, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 13, 1992. Regulation: 8.