510(k) K843717
K843717 is an FDA 510(k) premarket notification submitted by Viratek, Inc. for the device "VIRATEK SMALL PARTICLE AEROSOL GENERAT". The FDA issued a decision of Substantially Equivalent on December 30, 1985. Viratek, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 1985
- Date Received
- September 21, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No