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510(k) K900439

SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC by L H M Ent., Inc. — Product Code FIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1990
Date Received
January 29, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion Or Syringe, Extra-Luminal
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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  • K894610 — CUSTOM TRAYS, KITS (March 15, 1990)
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  • K883506 — IRRIGATION KIT (December 13, 1988)

Other clearances for product code FIH

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  • K931113 — CADD-TPN(TM) AMBULATORY INFUSION SYSTEM (April 28, 1994)
  • K881707 — INTROCULAR FLUID INJECTOR (October 21, 1988)