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510(k) K100192

STRONG DENTAL HANDPIECES by Saeshin Precision Co., Ltd. — Product Code EGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2010
Date Received
January 22, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Handpiece, Contra- And Right-Angle Attachment, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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