510(k) K861490

PERMACLEAR SOLUTION CAT. NO. 4950 by Helena Laboratories — Product Code KEM

K861490 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "PERMACLEAR SOLUTION CAT. NO. 4950". The FDA issued a decision of Substantially Equivalent on May 6, 1986. The device falls under product code KEM (Agent, Clearing), a Class I device regulated under 21 CFR 864.4010. Helena Laboratories has at least 10 other 510(k) clearances on record.