The following data is part of a premarket notification filed by Circulator Boot Corp. with the FDA for Circulator Boot.
Device ID | K082134 |
510k Number | K082134 |
Device Name: | CIRCULATOR BOOT |
Classification | Device, Counter-pulsating, External |
Applicant | CIRCULATOR BOOT CORP. 72 PENNSYLVANIA AVE. Malvern, PA 19355 |
Contact | Richard S Dillon |
Correspondent | Richard S Dillon CIRCULATOR BOOT CORP. 72 PENNSYLVANIA AVE. Malvern, PA 19355 |
Product Code | DRN |
CFR Regulation Number | 870.5225 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-07-29 |
Decision Date | 2009-05-07 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CIRCULATOR BOOT 75853332 2452741 Live/Registered |
CIRCULATOR BOOT COMPANY, LLC 1999-11-18 |