510(k) K953058

ROUND STICK SPONGES, FLAT STICK SPONGES by Medical Perspectives Corp. — Product Code GDY

K953058 is an FDA 510(k) premarket notification submitted by Medical Perspectives Corp. for the device "ROUND STICK SPONGES, FLAT STICK SPONGES". The FDA issued a decision of Substantially Equivalent on September 14, 1995. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Medical Perspectives Corp. has at least 6 other 510(k) clearances on record.