510(k) K896533

SPENCO BREAST FORMS by Spenco Medical Corp. — Product Code KCZ

K896533 is an FDA 510(k) premarket notification submitted by Spenco Medical Corp. for the device "SPENCO BREAST FORMS". The FDA issued a decision of Substantially Equivalent on December 13, 1989. The device falls under product code KCZ (Prosthesis, Breast, External, Used With Adhesive), a Class I device regulated under 21 CFR 878.3800. Spenco Medical Corp. has at least 9 other 510(k) clearances on record.