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510(k) K952893

THE SWIRLER AEROSOL SYSTEM by Amici, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1995
Date Received
June 23, 1995
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 Amici, Inc.

  • K063716 — AEROSOL SYSTEM (December 28, 2007)
  • K952910 — THE SWIRLER NEBULIZER (March 19, 1997)
  • K903805 — AMICI XENON ADMINISTRATION SET (January 14, 1991)
  • K904684 — AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION (January 14, 1991)
  • K903694 — AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE (October 3, 1990)
  • K872920 — AMICI KRYPTON ADMINISTRATION SYSTEM* (February 12, 1988)
  • K865084 — AMICI XENON REBREATHING SYSTEM* (March 3, 1987)

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