510(k) K791001

PENLIGHT/SWAB HOLDER by Concept, Inc. — Product Code KYT

K791001 is an FDA 510(k) premarket notification submitted by Concept, Inc. for the device "PENLIGHT/SWAB HOLDER". The FDA issued a decision of Substantially Equivalent on June 22, 1979. The device falls under product code KYT (Light, Examination, Medical, Battery Powered), a Class I device regulated under 21 CFR 880.6350. Concept, Inc. has at least 10 other 510(k) clearances on record.