510(k) K003056

OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218 by Labotect Labor-Technik Gottingen — Product Code MQE

K003056 is an FDA 510(k) premarket notification submitted by Labotect Labor-Technik Gottingen for the device "OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218". The FDA issued a decision of Substantially Equivalent on December 13, 2000. The device falls under product code MQE (Needle, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6100. Labotect Labor-Technik Gottingen has at least 2 other 510(k) clearances on record.