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510(k) K982839

CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300 by Sims Deltec, Inc. — Product Code MEA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1998
Date Received
August 12, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K991255 — CADD-TPN ADMINISTRATION SET, MODEL 21-7071 (June 9, 1999)
  • K990083 — CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECU (February 12, 1999)

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