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510(k) K973012

MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM by MDC Research , Ltd. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1997
Date Received
August 13, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by MDC Research , Ltd.

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