510(k) K902921

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

K902921 is an FDA 510(k) premarket notification submitted by American Silk Sutures, Inc. for the device "RAYON NEUROLOGICAL SPONGE". The FDA issued a decision of Substantially Equivalent on September 18, 1990. 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.