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510(k) K982136

JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200 by Schiff & Co. — Product Code DTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1999
Date Received
June 17, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reservoir, Blood, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4400
Review Panel
CV
Submission Type

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  • K943521 — VIOTEC 1400 SERIES ULTRAVIOLET GERMICIDAL FIXTURE (February 14, 1995)
  • K896684 — KEMBLE LIQUID HANDLING SYSTEM DISPENSER (April 16, 1990)
  • K894617 — OLYMPUS PK-TP SYSTEM REACTIVE CONTROL (October 31, 1989)

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