The following data is part of a premarket notification filed by Bffl Co. Inc with the FDA for Chabner Xrt Garments.
| Device ID | K121284 |
| 510k Number | K121284 |
| Device Name: | CHABNER XRT GARMENTS |
| Classification | Accelerator, Linear, Medical |
| Applicant | BFFL CO. INC 600 NEW HAMPSHIRE AVENUE NW SUITE 500 Washington, DC 20037 |
| Contact | Evan P Phelps |
| Correspondent | Evan P Phelps BFFL CO. INC 600 NEW HAMPSHIRE AVENUE NW SUITE 500 Washington, DC 20037 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-30 |
| Decision Date | 2013-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841439111673 | K121284 | 000 |
| 00860011294924 | K121284 | 000 |
| 00860011294917 | K121284 | 000 |
| 00860011294900 | K121284 | 000 |
| 00860011280194 | K121284 | 000 |
| 00860011280187 | K121284 | 000 |
| 00860011280170 | K121284 | 000 |
| 00860011280163 | K121284 | 000 |
| 00860011280156 | K121284 | 000 |
| 00860011280149 | K121284 | 000 |
| 00860011280132 | K121284 | 000 |
| 00860011280125 | K121284 | 000 |
| 00860011280118 | K121284 | 000 |
| 00841439112717 | K121284 | 000 |
| 00841439112724 | K121284 | 000 |
| 00841439111666 | K121284 | 000 |
| 00841439111659 | K121284 | 000 |
| 00841439111642 | K121284 | 000 |
| 00841439111635 | K121284 | 000 |
| 00841439111628 | K121284 | 000 |
| 00841439111611 | K121284 | 000 |
| 00841439111604 | K121284 | 000 |
| 00841439111598 | K121284 | 000 |
| 00841439111581 | K121284 | 000 |
| 10841439112844 | K121284 | 000 |
| 00841439112748 | K121284 | 000 |
| 00841439112731 | K121284 | 000 |
| 00860011280101 | K121284 | 000 |