510(k) K955713

NOBELPHARMA BONE ANCHORED HEARING AID by Nobelpharma USA, Inc. — Product Code LXB

K955713 is an FDA 510(k) premarket notification submitted by Nobelpharma USA, Inc. for the device "NOBELPHARMA BONE ANCHORED HEARING AID". The FDA issued a decision of Substantially Equivalent on August 9, 1996. The device falls under product code LXB (Hearing Aid, Bone Conduction), a Class II device regulated under 21 CFR 874.3302. Nobelpharma USA, Inc. has at least 10 other 510(k) clearances on record.