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510(k) K842305

C.A.P.D. AUTOMATIC HEATER PDH 200 by Medionics International , Ltd. — Product Code FKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1984
Date Received
June 12, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Peritoneal, Automatic Delivery
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

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  • K832141 — MICROSTAR VC1 VOLUMETRIC CYCLER (October 14, 1983)
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  • K821328 — C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP (July 28, 1982)

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