510(k) K954718

ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE by Ellman Intl., Inc. — Product Code HEE

K954718 is an FDA 510(k) premarket notification submitted by Ellman Intl., Inc. for the device "ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE". The FDA issued a decision of Substantially Equivalent on February 29, 1996. The device falls under product code HEE (Set, Anesthesia, Paracervical), a Class II device regulated under 21 CFR 884.5100. Ellman Intl., Inc. has at least 10 other 510(k) clearances on record.