510(k) K827123
K827123 is an FDA 510(k) premarket notification submitted by Ultralite for the device "SPECTRA (ULTRAVIOLET PRODUCTS)". The FDA issued a decision of Substantially Equivalent on March 5, 1982. Ultralite has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 1982
- Date Received
- February 2, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No