The following data is part of a premarket notification filed by Whitman Medical Corp. with the FDA for Gordon Ivs Intravenous Stabilizer.
Device ID | K790946 |
510k Number | K790946 |
Device Name: | GORDON IVS INTRAVENOUS STABILIZER |
Classification | Prosthesis, Adhesive, External |
Applicant | WHITMAN MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GBJ |
CFR Regulation Number | 878.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-05-18 |
Decision Date | 1979-06-05 |