510(k) K801504

HOLLISTER DRAINAGE POUCH by Hollister, Inc. — Product Code FON

K801504 is an FDA 510(k) premarket notification submitted by Hollister, Inc. for the device "HOLLISTER DRAINAGE POUCH". The FDA issued a decision of Substantially Equivalent on August 12, 1980. The device falls under product code FON (Bag, Drainage, With Adhesive, Ostomy), a Class I device regulated under 21 CFR 876.5900. Hollister, Inc. has at least 10 other 510(k) clearances on record.