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510(k) K052811

HSINER JET NEBULIZER, MODEL HS-31100 by Hsiner Co., Ltd. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2005
Date Received
October 4, 2005
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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