ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICE

Sleeve, Limb, Compressible

DEVON MEDICAL INC.

The following data is part of a premarket notification filed by Devon Medical Inc. with the FDA for Arterioflow Model 7500 Sequential Compression Device.

Pre-market Notification Details

Device IDK102582
510k NumberK102582
Device Name:ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICE
ClassificationSleeve, Limb, Compressible
Applicant DEVON MEDICAL INC. 1100 1ST AVENUE SUITE 100 King Of Prussia,  PA  19406
ContactRuth Wu
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2010-09-08
Decision Date2010-10-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10879766005416 K102582 000
10879766005409 K102582 000
10879766005232 K102582 000

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