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510(k) K904716

AERO-GEN NEBULIZER by Tri/Bor Medical, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 1991
Date Received
October 18, 1990
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 Tri/Bor Medical, Inc.

  • K904718 — AERO-GEN NUBULIZER SYSTEM (April 1, 1991)
  • K904717 — MICRO-VENT NEBULIZER SYSTEM (April 1, 1991)
  • K904715 — OXYGEN/AIR TUBING (January 2, 1991)
  • K904719 — DISPOSABLE FACE MASK (January 2, 1991)

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