510(k) K950108

R-MED MINI-RETRACTOR by R-Med, Inc. — Product Code HET

K950108 is an FDA 510(k) premarket notification submitted by R-Med, Inc. for the device "R-MED MINI-RETRACTOR". The FDA issued a decision of Substantially Equivalent on May 11, 1995. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. R-Med, Inc. has at least 8 other 510(k) clearances on record.