510(k) K960584

NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLY by Novavision, Inc. — Product Code HQD

K960584 is an FDA 510(k) premarket notification submitted by Novavision, Inc. for the device "NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLY". The FDA issued a decision of Substantially Equivalent on August 15, 1996. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916. Novavision, Inc. has at least 2 other 510(k) clearances on record.