510(k) K964387

POINT OF USE II SHARPS-A-GATOR by Graphic Controls Corp. — Product Code MMK

K964387 is an FDA 510(k) premarket notification submitted by Graphic Controls Corp. for the device "POINT OF USE II SHARPS-A-GATOR". The FDA issued a decision of Substantially Equivalent on March 27, 1997. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. Graphic Controls Corp. has at least 10 other 510(k) clearances on record.