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510(k) K992986

SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER by Salter Labs — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1999
Date Received
September 3, 1999
Clearance Type
Special
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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