The following data is part of a premarket notification filed by Keller And Heckman with the FDA for Cetylcide-g.
| Device ID | K974188 |
| 510k Number | K974188 |
| Device Name: | CETYLCIDE-G |
| Classification | Sterilant, Medical Devices |
| Applicant | KELLER AND HECKMAN 1001 G STREET, N.W. SUITE 500 WEST Washington, DC 20001 |
| Contact | John S Eldred |
| Correspondent | John S Eldred KELLER AND HECKMAN 1001 G STREET, N.W. SUITE 500 WEST Washington, DC 20001 |
| Product Code | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-07 |
| Decision Date | 1998-09-10 |
| Summary: | summary |