The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for I.v. Catheter Placement Unit Polyureth.
| Device ID | K830972 |
| 510k Number | K830972 |
| Device Name: | I.V. CATHETER PLACEMENT UNIT POLYURETH |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | CRITIKON COMPANY,LLC 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-28 |
| Decision Date | 1983-04-27 |