510(k) K862340

SENTEC LASER GUIDE LINE, MODEL SGL-05 by Sentec Corp. — Product Code IZW

K862340 is an FDA 510(k) premarket notification submitted by Sentec Corp. for the device "SENTEC LASER GUIDE LINE, MODEL SGL-05". The FDA issued a decision of Substantially Equivalent on July 11, 1986. The device falls under product code IZW (Collimator, Automatic, Radiographic), a Class II device regulated under 21 CFR 892.1610. Sentec Corp. has at least 6 other 510(k) clearances on record.