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FDA 510(k), K153513, Insufflator 50L FM134
FDA 510(k), K153513, Insufflator 50L FM134
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510(K) Number: K153513
Device Name: Insufflator 50L FM134
Manufacturer: W.O.M WORLD OF MEDICINE GMBH
Device Classification Name: insufflator, laparoscopic
Regulation Number: 884.1730
Classification Product Code: HIF
Date Received: 12/07/2015
Decision Date: 03/04/2016
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: Insufflator 50L FM134
Manufacturer: W.O.M WORLD OF MEDICINE GMBH
Device Classification Name: insufflator, laparoscopic
Regulation Number: 884.1730
Classification Product Code: HIF
Date Received: 12/07/2015
Decision Date: 03/04/2016
Regulation Medical Specialty: Obstetrics/Gynecology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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