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510(k) K870051

SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLE by Viratek, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1987
Date Received
January 6, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

Other clearances by Viratek, Inc.

  • K896608 — SPAG PAK (April 9, 1990)
  • K882396 — AEROSOL DELIVERY HOOD (August 1, 1988)
  • K871427 — (SPAG) MODEL SPAG-2 6000 SERIES (October 6, 1987)
  • K843717 — VIRATEK SMALL PARTICLE AEROSOL GENERAT (December 30, 1985)

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