The following data is part of a premarket notification filed by Signal Medical Corp. with the FDA for E-z Frame External Surgical Support Boot.
| Device ID | K043289 |
| 510k Number | K043289 |
| Device Name: | E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SIGNAL MEDICAL CORP. 400 PYRAMID DR. Marysville, MI 48040 |
| Contact | Louis A Serafin, Jr. |
| Correspondent | Louis A Serafin, Jr. SIGNAL MEDICAL CORP. 400 PYRAMID DR. Marysville, MI 48040 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-29 |
| Decision Date | 2005-02-11 |
| Summary: | summary |