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510(k) K063716

AEROSOL SYSTEM by Amici, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 2007
Date Received
December 14, 2006
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.

  • K952910 — THE SWIRLER NEBULIZER (March 19, 1997)
  • K952893 — THE SWIRLER AEROSOL SYSTEM (November 3, 1995)
  • 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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