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510(k) K903580

MICRO-MISTER by Bp , Ltd. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1990
Date Received
August 8, 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 Bp , Ltd.

  • K904196 — MICRO-MIST NEBULIZER (December 21, 1990)
  • K904195 — DISPOSABLE FACE MASK (September 25, 1990)

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