FDA 510(k), K112488, HOTDOG PATIENT WARMING SYSTEM

FDA 510(k), K112488, HOTDOG PATIENT WARMING SYSTEM

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510(K) Number: K112488
Device Name: HOTDOG PATIENT WARMING SYSTEM
Manufacturer: AUGUSTINE BIOMEDICAL & DESIGN, LLC
Device Classification Name: system, thermal regulating
Regulation Number: 870.5900
Classification Product Code: DWJ
Date Received: 08/29/2011
Decision Date: 11/23/2011
Regulation Medical Specialty: Cardiovascular
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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