510(k) K854713

COTTON NEUROLOGICAL SPONGE by American Silk Sutures, Inc. — Product Code HBA

K854713 is an FDA 510(k) premarket notification submitted by American Silk Sutures, Inc. for the device "COTTON NEUROLOGICAL SPONGE". The FDA issued a decision of Substantially Equivalent on March 20, 1986. The device falls under product code HBA (Neurosurgical Paddie), a Class II device regulated under 21 CFR 882.4700. American Silk Sutures, Inc. has at least 10 other 510(k) clearances on record.