510(k) K003630

DANMAR PRODUCTS MICHIGAN CRANIAL HELMET by Danmar Products, Inc. — Product Code MVA

K003630 is an FDA 510(k) premarket notification submitted by Danmar Products, Inc. for the device "DANMAR PRODUCTS MICHIGAN CRANIAL HELMET". The FDA issued a decision of Substantially Equivalent on May 29, 2001. The device falls under product code MVA (Orthosis, Cranial), a Class II device regulated under 21 CFR 882.5970. Danmar Products, Inc. has at least 2 other 510(k) clearances on record.