The following data is part of a premarket notification filed by Stephens Scientific with the FDA for Decalcifying Solution Ii.
| Device ID | K881359 |
| 510k Number | K881359 |
| Device Name: | DECALCIFYING SOLUTION II |
| Classification | Solvent, Adhesive Tape |
| 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 | KOX |
| CFR Regulation Number | 878.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-31 |
| Decision Date | 1988-04-19 |