510(k) K922402

4 SURE TM ENTERAL FEEDING BAG by Boston Pacific Medical, Inc. — Product Code FPD

K922402 is an FDA 510(k) premarket notification submitted by Boston Pacific Medical, Inc. for the device "4 SURE TM ENTERAL FEEDING BAG". The FDA issued a decision of Substantially Equivalent on March 25, 1994. The device falls under product code FPD (Tube, Feeding), a Class II device regulated under 21 CFR 876.5980. Boston Pacific Medical, Inc. has at least 10 other 510(k) clearances on record.