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510(k) K072921

DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM by Symbios Medical Products, LLC — Product Code MEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2007
Date Received
October 15, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Elastomeric
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Symbios Medical Products, LLC

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  • K081905 — ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP (July 15, 2008)
  • K071532 — ALPHA INFUSION PUMP, MODEL A200, A450 (February 19, 2008)
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