510(k) K861028
K861028 is an FDA 510(k) premarket notification submitted by Keta Corp. for the device "SUPERLITE PENLIGHT". The FDA issued a decision of Substantially Equivalent on April 4, 1986. Keta Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 1986
- Date Received
- March 18, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No