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FDA 510(k), K021716, SIMPLIFY COMPACT RESUSCITATOR
FDA 510(k), K021716, SIMPLIFY COMPACT RESUSCITATOR
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510(K) Number: K021716
Device Name: SIMPLIFY COMPACT RESUSCITATOR
Manufacturer: POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD.
Device Classification Name: ventilator, emergency, manual (resuscitator)
Regulation Number: 868.5915
Classification Product Code: BTM
Date Received: 05/23/2002
Decision Date: 10/08/2002
Regulation Medical Specialty: Anesthesiology
Device Name: SIMPLIFY COMPACT RESUSCITATOR
Manufacturer: POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD.
Device Classification Name: ventilator, emergency, manual (resuscitator)
Regulation Number: 868.5915
Classification Product Code: BTM
Date Received: 05/23/2002
Decision Date: 10/08/2002
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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