The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Paraplast Extra Tissue Embedding Med..
| Device ID | K842053 |
| 510k Number | K842053 |
| Device Name: | PARAPLAST EXTRA TISSUE EMBEDDING MED. |
| Classification | Formulations, Paraffin, All |
| Applicant | SHERWOOD MEDICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KEO |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-22 |
| Decision Date | 1984-06-26 |