
Kontron Instruments, Inc.
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SIGMA 1 WOBBLER BIOPSY KIT is an FDA 510(k)-cleared medical device (K882673) manufactured by Kontron Instruments, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 27, 1988. Regulation: 8.