510(k) K921852

4 SURE TM RECTAL TUBE by Boston Pacific Medical, Inc. — Product Code KMO

K921852 is an FDA 510(k) premarket notification submitted by Boston Pacific Medical, Inc. for the device "4 SURE TM RECTAL TUBE". The FDA issued a decision of Substantially Equivalent on October 8, 1993. The device falls under product code KMO (Binder, Elastic), a Class I device regulated under 21 CFR 880.5160. Boston Pacific Medical, Inc. has at least 10 other 510(k) clearances on record.