510(k) K822711

ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL by Parker Laboratories, Inc. — Product Code FAX

K822711 is an FDA 510(k) premarket notification submitted by Parker Laboratories, Inc. for the device "ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL". The FDA issued a decision of Substantially Equivalent on November 3, 1982. The device falls under product code FAX (Bougie, Urological), a Class I device regulated under 21 CFR 876.5520. Parker Laboratories, Inc. has at least 10 other 510(k) clearances on record.