The following data is part of a premarket notification filed by Circulator Boot Corp. with the FDA for The Circulator Boot.
Device ID | K792354 |
510k Number | K792354 |
Device Name: | THE CIRCULATOR BOOT |
Classification | Device, Counter-pulsating, External |
Applicant | CIRCULATOR BOOT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DRN |
CFR Regulation Number | 870.5225 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-20 |
Decision Date | 1980-01-09 |