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510(k) K962085

SALTER LABS 8990 SERIES NEBULIZER by Salter Labs — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1996
Date Received
May 29, 1996
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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