The following data is part of a premarket notification filed by Baka Manufacturing Co., Inc. with the FDA for Grip, Hospital Utility.
Device ID | K781800 |
510k Number | K781800 |
Device Name: | GRIP, HOSPITAL UTILITY |
Classification | Device, Intravascular Catheter Securement |
Applicant | BAKA MANUFACTURING CO., INC. 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 | 1978-10-23 |
Decision Date | 1978-12-07 |