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 |