FDA 510(k), K002705, EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400

FDA 510(k), K002705, EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400

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510(K) Number: K002705
Device Name: EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400
Manufacturer: CARL STEINECK
Device Classification Name: Set, I.V. Fluid Transfer
Regulation Number: LHI
Classification Product Code: KXA
Date Received: 08/30/2000
Decision Date: 03/28/2001
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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