510(k) K813548

UVEX MINI-SPECS by Bacou USA, Inc. and Uvex Safety, Inc. — Product Code HOI

K813548 is an FDA 510(k) premarket notification submitted by Bacou USA, Inc. and Uvex Safety, Inc. for the device "UVEX MINI-SPECS". The FDA issued a decision of Substantially Equivalent on March 2, 1982. The device falls under product code HOI (Spectacle, Magnifying), a Class I device regulated under 21 CFR 886.5840. Bacou USA, Inc. and Uvex Safety, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1982
Date Received
December 21, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spectacle, Magnifying
Device Class
Class I
Regulation Number
886.5840
Review Panel
OP
Submission Type