510(k) K823825
K823825 is an FDA 510(k) premarket notification submitted by Patton, Boggs & Blow for the device "NOSITE UV INTERIM SPECTACLES". The FDA issued a decision of Substantially Equivalent on February 24, 1983. The device falls under product code HQG (Lens, Spectacle, Non-Custom (Prescription)), a Class I device regulated under 21 CFR 886.5844. Patton, Boggs & Blow has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 1983
- Date Received
- December 20, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lens, Spectacle, Non-Custom (Prescription)
- Device Class
- Class I
- Regulation Number
- 886.5844
- Review Panel
- OP
- Submission Type