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510(k) K963595

SERAGARD VASCULAR ACCESS DEVICE by Cutting Edge Technologies, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1997
Date Received
September 9, 1996
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 Cutting Edge Technologies, Inc.

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