510(k) K822032

LARGE VOLUME CLOSED WOUND SUCTION DRAIN by American Heyer Schulte — Product Code GCY

K822032 is an FDA 510(k) premarket notification submitted by American Heyer Schulte for the device "LARGE VOLUME CLOSED WOUND SUCTION DRAIN". The FDA issued a decision of Substantially Equivalent on August 16, 1982. The device falls under product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered), a Class I device regulated under 21 CFR 878.4680. American Heyer Schulte has at least 10 other 510(k) clearances on record.