The following data is part of a premarket notification filed by Devon Medical Inc. with the FDA for Circuflow 5208 Sequential Compression Device.
Device ID | K123647 |
510k Number | K123647 |
Device Name: | CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE |
Classification | Sleeve, Limb, Compressible |
Applicant | DEVON MEDICAL INC. 1100 1ST AVENUE SUITE 100 King Of Prussia, PA 19406 |
Contact | Ruth Wu |
Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2012-11-27 |
Decision Date | 2013-02-14 |
Summary: | summary |