The following data is part of a premarket notification filed by Cilco, Inc. with the FDA for Cilco I/a Surgical Pack.
| Device ID | K843319 |
| 510k Number | K843319 |
| Device Name: | CILCO I/A SURGICAL PACK |
| Classification | Unit, Phacofragmentation |
| Applicant | CILCO, INC. 1616 13TH. AVE. SUITE 200 Huntington, WV 25701 |
| Contact | Rich Mccarley |
| Correspondent | Rich Mccarley CILCO, INC. 1616 13TH. AVE. SUITE 200 Huntington, WV 25701 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-24 |
| Decision Date | 1985-02-14 |