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510(k) K961476

SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984) by Salter Labs — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1996
Date Received
April 18, 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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