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510(k) K881062

CENTRY 2 ULTRAFILTRATION CONTROL KIT, #018762-002 by Cobe Laboratories, Inc. — Product Code FJB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1988
Date Received
March 14, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector, Dialysate Level
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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Other clearances for product code FJB

  • K883490 — ACCUFLO UF CONTROL MODULE NO. 74-0100-3 (September 29, 1988)
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