The following data is part of a premarket notification filed by Health Line International Corporation (hlic) with the FDA for Orion Ii Ct Cvc.
| Device ID | K113622 |
| 510k Number | K113622 |
| Device Name: | ORION II CT CVC |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | HEALTH LINE INTERNATIONAL CORPORATION (HLIC) 803 North 1250 West Suite 1 Centerville, UT 84014 |
| Contact | Nola Benstog |
| Correspondent | Nola Benstog HEALTH LINE INTERNATIONAL CORPORATION (HLIC) 803 North 1250 West Suite 1 Centerville, UT 84014 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-08 |
| Decision Date | 2012-05-18 |
| Summary: | summary |