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510(k) K041655

BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS) by Cowellmedi Co., Ltd. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2004
Date Received
June 18, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

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