The following data is part of a premarket notification filed by Pacific Medical Industries with the FDA for Silicone Oil 350 Cnetistoke.
| Device ID | K854273 |
| 510k Number | K854273 |
| Device Name: | SILICONE OIL 350 CNETISTOKE |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | PACIFIC MEDICAL INDUSTRIES 3134 BUNCHE AVE. San Diego, CA 92122 |
| Contact | Charles W Kerber |
| Correspondent | Charles W Kerber PACIFIC MEDICAL INDUSTRIES 3134 BUNCHE AVE. San Diego, CA 92122 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-20 |
| Decision Date | 1985-11-22 |