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510(k) K980407

HOPE NEBULIZER by B&B Medical Technologies, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1998
Date Received
February 3, 1998
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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  • K925386 — ADHESIVE E.T. TAPE (April 19, 1993)
  • K923690 — MINI HEART (October 20, 1992)
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  • K913753 — BODAI NEO2 -SAFE AIRWAY PRESSURE CAP (October 23, 1991)
  • K913000 — HEART NEBULIZER POLE CLAMP (August 2, 1991)

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