The following data is part of a premarket notification filed by Molecular Products Ltd. with the FDA for Sofnolime Carbon Dioxide Absorbent.
| Device ID | K921803 |
| 510k Number | K921803 |
| Device Name: | SOFNOLIME CARBON DIOXIDE ABSORBENT |
| Classification | Absorbent, Carbon-dioxide |
| Applicant | MOLECULAR PRODUCTS LTD. MILL END Thaxted, Essex, GB Cm6 2lt |
| Contact | Crickmore |
| Correspondent | Crickmore MOLECULAR PRODUCTS LTD. MILL END Thaxted, Essex, GB Cm6 2lt |
| Product Code | CBL |
| CFR Regulation Number | 868.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-15 |
| Decision Date | 1992-10-15 |