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FDA 510(k) Applications Submitted by Jasper Benke
FDA 510(k) Number
Submission Date
Device Name
Applicant
K190487
02/28/2019
InPen Dose Calculator
Companion Medical, Inc.
K160629
03/07/2016
InPen
COMPANION MEDICAL, INC.
K061367
05/16/2006
BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500
BLUE SKY MEDICAL GROUP INCORPORATED
K181327
05/18/2018
InPen Dose Calculator
Companion Medical, Inc.
K201337
05/20/2020
InPen System
Companion Medical, Inc.
K061919
07/06/2006
VERSATILE 1 EZCARE WOUND VACUUM SYSTEM
BLUE SKY MEDICAL GROUP INCORPORATED
K081932
07/07/2008
ENDEARE BREAST PUMP
HYGEIA MEDICAL, INC.
K052456
09/07/2005
MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM
BLUE SKY MEDICAL GROUP INCORPORATED
K192841
10/03/2019
InPen System
Companion Medical, Inc.
K083102
10/20/2008
REFINE LIFT SYSTEM
ALURE MEDICAL INC.
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