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FDA 510(k), K101702, MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS
FDA 510(k), K101702, MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS
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510(K) Number: K101702
Device Name: MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS
Manufacturer: JEROME JAMES
Device Classification Name: Sleeve, Limb, Compressible
Regulation Number: JOW
Classification Product Code: 06/17/2010
Date Received: 08/27/2010
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS
Manufacturer: JEROME JAMES
Device Classification Name: Sleeve, Limb, Compressible
Regulation Number: JOW
Classification Product Code: 06/17/2010
Date Received: 08/27/2010
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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