The following data is part of a premarket notification filed by Fred Sammons, Inc. with the FDA for Ultra-pan For Orthotic Plastics (7262).
| Device ID | K880644 |
| 510k Number | K880644 |
| Device Name: | ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) |
| Classification | Unit, Heating, Powered |
| Applicant | FRED SAMMONS, INC. 145 TOWER DR. Burr Ridge, IL 60521 |
| Contact | Susan Bledsoe |
| Correspondent | Susan Bledsoe FRED SAMMONS, INC. 145 TOWER DR. Burr Ridge, IL 60521 |
| Product Code | IRQ |
| CFR Regulation Number | 890.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-16 |
| Decision Date | 1988-05-06 |