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510(k) K894427

DISPOSABLE IV INDUCTION COVER by Central Plastic, Inc. — Product Code FMK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1989
Date Received
July 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Device Class
Class II
Regulation Number
878.4850
Review Panel
SU
Submission Type

A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.

Other clearances by Central Plastic, Inc.

  • K910104 — ANTI-FOG DISPOSABLE IV INDUCTION COVER (April 12, 1991)

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