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FDA 510(k), K781990, CARDIAC INSULATION PAD
FDA 510(k), K781990, CARDIAC INSULATION PAD
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510(K) Number: K781990
Device Name: CARDIAC INSULATION PAD
Manufacturer: SHILEY, INC.
Device Classification Name: catheter, cannula and tubing, vascular, cardiopulmonary bypass
Regulation Number: 870.4210
Classification Product Code: DWF
Date Received: 11/27/1978
Decision Date: 12/04/1978
Regulation Medical Specialty: Cardiovascular
Device Name: CARDIAC INSULATION PAD
Manufacturer: SHILEY, INC.
Device Classification Name: catheter, cannula and tubing, vascular, cardiopulmonary bypass
Regulation Number: 870.4210
Classification Product Code: DWF
Date Received: 11/27/1978
Decision Date: 12/04/1978
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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