510(k) K892360

WATER JEL STERILE GEL-SOAKED BURN DRESSING by Pfizer, Inc. — Product Code FRO

K892360 is an FDA 510(k) premarket notification submitted by Pfizer, Inc. for the device "WATER JEL STERILE GEL-SOAKED BURN DRESSING". The FDA issued a decision of Substantially Equivalent on June 5, 1989. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Pfizer, Inc. has at least 10 other 510(k) clearances on record.