510(k) K870320

DACOMED PENILE PROSTHESIS SIZER by Dacomed Corp. — Product Code JLW

K870320 is an FDA 510(k) premarket notification submitted by Dacomed Corp. for the device "DACOMED PENILE PROSTHESIS SIZER". The FDA issued a decision of Substantially Equivalent on March 17, 1987. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Dacomed Corp. has at least 10 other 510(k) clearances on record.