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510(k) K991404

PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP) by Itl Corporation Pty, Ltd. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1999
Date Received
April 22, 1999
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

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  • K000777 — SAMPLOK (April 11, 2000)

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