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510(k) K060971

OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS by Omi Manufacturing Pty., Ltd. — Product Code MEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2006
Date Received
April 7, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Antistick
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

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