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510(k) K781795

DIALYZER, PARALLEL FLOW DISPOSABLE by Medical, Inc. — Product Code FJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1978
Date Received
October 25, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Parallel Flow
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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  • K820694 — COBE PPD 1.3L, #18-520-009 (March 31, 1982)
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