The following data is part of a premarket notification filed by Circulator Boot Corp. with the FDA for The Circulator Boot.
| Device ID | K971026 |
| 510k Number | K971026 |
| Device Name: | THE CIRCULATOR BOOT |
| Classification | Device, Counter-pulsating, External |
| Applicant | CIRCULATOR BOOT CORP. 150 MILL CREEK RD. Ardmore, PA 19003 |
| Contact | Richard S Dillon |
| Correspondent | Richard S Dillon CIRCULATOR BOOT CORP. 150 MILL CREEK RD. Ardmore, PA 19003 |
| Product Code | DRN |
| CFR Regulation Number | 870.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-20 |
| Decision Date | 1997-08-14 |
| Summary: | summary |