510(k) K101141

SEILER COLPOSCOPE, MODELS 935, 955 AND 985 by Seiler Precision Microscopes — Product Code HEX

K101141 is an FDA 510(k) premarket notification submitted by Seiler Precision Microscopes for the device "SEILER COLPOSCOPE, MODELS 935, 955 AND 985". The FDA issued a decision of Substantially Equivalent on August 6, 2010. The device falls under product code HEX (Colposcope (And Colpomicroscope)), a Class II device regulated under 21 CFR 884.1630.