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FDA 510(k), K173489, GYN-Pump PH304
FDA 510(k), K173489, GYN-Pump PH304
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510(K) Number: K173489
Device Name: GYN-Pump PH304
Manufacturer: W.O.M. World of Medicine GmbH
Device Classification Name: insufflator, hysteroscopic
Regulation Number: 884.1700
Classification Product Code: HIG
Date Received: 11/13/2017
Decision Date: 03/28/2018
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: GYN-Pump PH304
Manufacturer: W.O.M. World of Medicine GmbH
Device Classification Name: insufflator, hysteroscopic
Regulation Number: 884.1700
Classification Product Code: HIG
Date Received: 11/13/2017
Decision Date: 03/28/2018
Regulation Medical Specialty: Obstetrics/Gynecology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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