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510(k) K102658

MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS by Thayer Medical Corp. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2010
Date Received
September 15, 2010
Clearance Type
Special
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 Thayer Medical Corp.

  • K993101 — LITEAIRE (October 26, 2000)
  • K992722 — PRIMEAIRE (November 10, 1999)
  • K972237 — HAND HELD MEDISPACER (July 31, 1997)
  • K955805 — DUAL SPRAY MINISPACER (March 21, 1996)
  • K941026 — THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR (August 18, 1994)
  • K924535 — THAYER HAND HELD M.K.I. HOLDING CHAMBER (March 10, 1993)
  • K914283 — THAYER EXPANSION CHAMBER METERED DOSE INHALER (February 26, 1992)
  • 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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  • K242354 — AllNEB (April 29, 2025)
  • K233553 — MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter (June 18, 2024)
  • K232507 — Aerogen®Solo Nebulizer System (May 10, 2024)
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