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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
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
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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