510(k) K090607

BLUE SKY BIO PLAN, VERSION .38 by Blue Sky Bio, LLC — Product Code LLZ

K090607 is an FDA 510(k) premarket notification submitted by Blue Sky Bio, LLC for the device "BLUE SKY BIO PLAN, VERSION .38". The FDA issued a decision of Substantially Equivalent on April 22, 2009. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Blue Sky Bio, LLC has at least 10 other 510(k) clearances on record.