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510(k) K052650

PIONEER U601 SERIES ASPIRATOR by Merits Health Products Co., Ltd. — Product Code BTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2005
Date Received
September 26, 2005
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

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