The following data is part of a premarket notification filed by Hazleton Research Products, Inc. with the FDA for Hepes Buffer Im In Normal Saline.
| Device ID | K844877 |
| 510k Number | K844877 |
| Device Name: | HEPES BUFFER IM IN NORMAL SALINE |
| Classification | Formulations, Balanced Salt Solutions |
| Applicant | HAZLETON RESEARCH PRODUCTS, INC. BOX 7200 Denver, PA 17517 |
| Contact | James K Noel |
| Correspondent | James K Noel HAZLETON RESEARCH PRODUCTS, INC. BOX 7200 Denver, PA 17517 |
| Product Code | KIP |
| CFR Regulation Number | 864.2875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-17 |
| Decision Date | 1985-02-25 |