510(k) K844838

SKIN STAT II SKIN STAPLING MEDICAL DEVICE by Edward Weck, Inc. — Product Code GDT

K844838 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "SKIN STAT II SKIN STAPLING MEDICAL DEVICE". The FDA issued a decision of Substantially Equivalent on January 23, 1985. The device falls under product code GDT (Staple, Removable (Skin)), a Class I device regulated under 21 CFR 878.4760. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.