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510(k) K971015

AHCS HEMOPERFUSION SYSTEM by American Health Care Systems, Inc. — Product Code FLD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1997
Date Received
March 20, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Hemoperfusion, Sorbent
Device Class
Class II
Regulation Number
876.5870
Review Panel
GU
Submission Type

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