The following data is part of a premarket notification filed by Devon Medical Inc. with the FDA for Arterioflow Model 7500 Sequential Compression Device.
Device ID | K102582 |
510k Number | K102582 |
Device Name: | ARTERIOFLOW MODEL 7500 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 | 2010-09-08 |
Decision Date | 2010-10-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10879766005416 | K102582 | 000 |
10879766005409 | K102582 | 000 |
10879766005232 | K102582 | 000 |