510(k) K982082

HANDISOL WOUND HEALING by National Biological Corp. — Product Code FTC

K982082 is an FDA 510(k) premarket notification submitted by National Biological Corp. for the device "HANDISOL WOUND HEALING". The FDA issued a decision of Substantially Equivalent on October 28, 1998. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630. National Biological Corp. has at least 10 other 510(k) clearances on record.