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510(k) K833780

CAPD PREP KIT by Professional Dialysis Products — Product Code FKG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 9, 1984
Date Received: October 28, 1983
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Tray, Start/Stop (Including Contents), Dialysis
Device Class: Class I
Regulation Number: 876.5820
Review Panel: GU
Submission Type