510(k) K820016

UVEX ALPHA, BETA, GAMMA & DELTA SUN by Bacou USA, Inc. and Uvex Safety, Inc. — Product Code HQY

K820016 is an FDA 510(k) premarket notification submitted by Bacou USA, Inc. and Uvex Safety, Inc. for the device "UVEX ALPHA, BETA, GAMMA & DELTA SUN". The FDA issued a decision of Substantially Equivalent on March 19, 1982. The device falls under product code HQY (Sunglasses (Non-Prescription Including Photosensitive)), a Class I device regulated under 21 CFR 886.5850. Bacou USA, Inc. and Uvex Safety, Inc. has at least 2 other 510(k) clearances on record.