510(k) K811239

SUR-FIT DISPOSABLE CONVEX INSERT by E. R. Squibb & Sons, Inc. — Product Code EXB

K811239 is an FDA 510(k) premarket notification submitted by E. R. Squibb & Sons, Inc. for the device "SUR-FIT DISPOSABLE CONVEX INSERT". The FDA issued a decision of Substantially Equivalent on June 9, 1981. The device falls under product code EXB (Collector, Ostomy), a Class I device regulated under 21 CFR 876.5900. E. R. Squibb & Sons, Inc. has at least 10 other 510(k) clearances on record.