510(k) K843717

VIRATEK SMALL PARTICLE AEROSOL GENERAT by Viratek, Inc.

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 Dec 30, 1985. Viratek, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 30, 1985
Date Received
Sep 21, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No