The following data is part of a premarket notification filed by Astral, Ltd. with the FDA for Kwik Board.
Device ID | K930197 |
510k Number | K930197 |
Device Name: | KWIK BOARD |
Classification | Device, Intravascular Catheter Securement |
Applicant | ASTRAL, LTD. 44 MARK DR. San Rafael, CA 94903 |
Product Code | KMK |
CFR Regulation Number | 880.5210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-14 |
Decision Date | 1993-04-20 |