510(k) K813548
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