510(k) K861292
K861292 is an FDA 510(k) premarket notification submitted by Walgen Medical Innoventions for the device "CASTALERT". The FDA issued a decision of Substantially Equivalent on May 12, 1986. Walgen Medical Innoventions has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 12, 1986
- Date Received
- April 7, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No