Patent Hemostasis Band (PH Band)

Clamp, Vascular

Medical Ingenuities

The following data is part of a premarket notification filed by Medical Ingenuities with the FDA for Patent Hemostasis Band (ph Band).

Pre-market Notification Details

Device IDK201695
510k NumberK201695
Device Name:Patent Hemostasis Band (PH Band)
ClassificationClamp, Vascular
Applicant Medical Ingenuities 345 Browning Court Wheaton,  IL  60189
ContactRichard "chip" Corrigan
CorrespondentValerie Defiesta-ng
Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose,  CA  95110
Product CodeDXC  
CFR Regulation Number870.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-22
Decision Date2020-10-30

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