The following data is part of a premarket notification filed by Fred Sammons, Inc. with the FDA for Sorbothane Visco Inner Sole Pad.
| Device ID | K831552 |
| 510k Number | K831552 |
| Device Name: | SORBOTHANE VISCO INNER SOLE PAD |
| Classification | Orthosis, Corrective Shoe |
| Applicant | FRED SAMMONS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KNP |
| CFR Regulation Number | 890.3475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-12 |
| Decision Date | 1983-06-08 |