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510(k) K874924

CAP-35 AND CAP35 F by Gish Biomedical, Inc. — Product Code DTP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 1988
Date Received
December 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Defoamer, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4230
Review Panel
CV
Submission Type

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  • K081881 — GISH TUBING AND CONNECTORS WITH HA COATING (January 23, 2009)

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  • K941654 — SARNS FILTERED VENOUS RESERVIOR MODIFICATION (July 26, 1994)
  • K933496 — MAXIMA FILTERED HARDSHELL RESERVIOR (October 15, 1993)
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