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510(k) K081694

DENJECTOR by Dxm Co., Ltd. — Product Code EJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2008
Date Received
June 17, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Cartridge
Device Class
Class II
Regulation Number
872.6770
Review Panel
DE
Submission Type

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