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510(k) K993101

LITEAIRE by Thayer Medical Corp. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2000
Date Received
September 16, 1999
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

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  • K924535 — THAYER HAND HELD M.K.I. HOLDING CHAMBER (March 10, 1993)
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  • K904917 — THAYER MIP ADAPTER (January 28, 1991)
  • K901739 — THAYER METERED DOSE INHALER DISPENSER/ADAPTER (October 9, 1990)
  • K900047 — THAYER SUCTION EVACUATION CONDENSATE COLLECTION (April 23, 1990)

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