The following data is part of a premarket notification filed by Georgetown Medical Co. with the FDA for Universal I.v. Holder.
| Device ID | K821317 |
| 510k Number | K821317 |
| Device Name: | UNIVERSAL I.V. HOLDER |
| Classification | Device, Intravascular Catheter Securement |
| Applicant | GEORGETOWN MEDICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KMK |
| CFR Regulation Number | 880.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-04 |
| Decision Date | 1982-05-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() UNIVERSAL I.V. HOLDER 73359514 1365402 Dead/Cancelled |
GEORGETOWN MEDICAL CO. 1982-04-12 |