The following data is part of a premarket notification filed by Hazleton Research Products, Inc. with the FDA for Gentamicin-50mg/ml.
| Device ID | K861869 |
| 510k Number | K861869 |
| Device Name: | GENTAMICIN-50MG/ML |
| Classification | Media And Components, Synthetic Cell And Tissue Culture |
| Applicant | HAZLETON RESEARCH PRODUCTS, INC. BOX 7200 Denver, PA 17517 |
| Contact | Noel, Ph.d. |
| Correspondent | Noel, Ph.d. HAZLETON RESEARCH PRODUCTS, INC. BOX 7200 Denver, PA 17517 |
| Product Code | KIT |
| CFR Regulation Number | 864.2220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-15 |
| Decision Date | 1986-05-29 |