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510(k) K972237

HAND HELD MEDISPACER by Thayer Medical Corp. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1997
Date Received
May 1, 1997
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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  • 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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