510(k) K111247

CRANIAL REMOLDING ORTHOSIS by Orthotic Care Services, Llp — Product Code MVA

K111247 is an FDA 510(k) premarket notification submitted by Orthotic Care Services, Llp for the device "CRANIAL REMOLDING ORTHOSIS". The FDA issued a decision of Substantially Equivalent on August 15, 2011. The device falls under product code MVA (Orthosis, Cranial), a Class II device regulated under 21 CFR 882.5970.