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510(k) K091716

MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY by Merits Health Products Co., Ltd. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2010
Date Received
June 10, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Oxygen, Portable
Device Class
Class II
Regulation Number
868.5440
Review Panel
AN
Submission Type

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