The following data is part of a premarket notification filed by Stephens Scientific with the FDA for Decalcifying Solution.
| Device ID | K872625 |
| 510k Number | K872625 |
| Device Name: | DECALCIFYING SOLUTION |
| Classification | Solution, Decalcifier, Acid Containing |
| Applicant | STEPHENS SCIENTIFIC 7 ASTRO PL., PO BOX 1116 Denville, NJ 07834 |
| Contact | James D Yeakel |
| Correspondent | James D Yeakel STEPHENS SCIENTIFIC 7 ASTRO PL., PO BOX 1116 Denville, NJ 07834 |
| Product Code | KDX |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-06 |
| Decision Date | 1987-08-06 |