MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL

MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL is an FDA 510(k)-cleared medical device (K895819) manufactured by Medi-Tech, Inc.. This device is classified under the General Hospital specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 1, 1989. Regulation: 8.