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510(k) K871427

(SPAG) MODEL SPAG-2 6000 SERIES by Viratek, Inc. — Product Code CAF

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
October 6, 1987
Date Received
April 9, 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)
  • K870051 — SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLE (October 6, 1987)
  • K843717 — VIRATEK SMALL PARTICLE AEROSOL GENERAT (December 30, 1985)

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