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510(k) K950739

3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM by 3M Health Care, Sarns — Product Code DWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1995
Date Received
February 17, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Pump Speed, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4380
Review Panel
CV
Submission Type

Other clearances by 3M Health Care, Sarns

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  • K941654 — SARNS FILTERED VENOUS RESERVIOR MODIFICATION (July 26, 1994)
  • K940651 — SARNS ULTRASONIC AIR SENSOR (May 24, 1994)
  • K935391 — SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PA (February 24, 1994)
  • K934127 — SARNS LOW JETTING AORTIC ARCH CANNULA (February 22, 1994)
  • K935977 — SARNS AIR DETECTION SYSTEM (February 4, 1994)
  • K915547 — SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT (September 9, 1993)
  • K925076 — SARNS TURBO MEMBRANE OXYGENA. W/INT. CARDIOTOMY R. (June 7, 1993)

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