The following data is part of a premarket notification filed by Allied Healthcare Products, Inc. with the FDA for Baralyme Co2 Absorbent.
| Device ID | K811260 |
| 510k Number | K811260 |
| Device Name: | BARALYME CO2 ABSORBENT |
| Classification | Absorbent, Carbon-dioxide |
| Applicant | ALLIED HEALTHCARE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CBL |
| CFR Regulation Number | 868.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-06 |
| Decision Date | 1981-05-27 |