The following data is part of a premarket notification filed by Stephens Scientific with the FDA for Tissue Embedding Medium.
| Device ID | K893772 |
| 510k Number | K893772 |
| Device Name: | TISSUE EMBEDDING MEDIUM |
| Classification | Formulations, Paraffin, All |
| Applicant | STEPHENS SCIENTIFIC 7 ASTRO PL., PO BOX 1116 Denville, NJ 07834 |
| Contact | R Savuto |
| Correspondent | R Savuto STEPHENS SCIENTIFIC 7 ASTRO PL., PO BOX 1116 Denville, NJ 07834 |
| Product Code | KEO |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-22 |
| Decision Date | 1989-06-22 |