510(k) K983754

STANDARD CHIN by Surgical Technology Laboratories, Inc. — Product Code FWP

K983754 is an FDA 510(k) premarket notification submitted by Surgical Technology Laboratories, Inc. for the device "STANDARD CHIN". The FDA issued a decision of Substantially Equivalent on November 20, 1998. The device falls under product code FWP (Prosthesis, Chin, Internal), a Class II device regulated under 21 CFR 878.3550. Surgical Technology Laboratories, Inc. has at least 10 other 510(k) clearances on record.