The following data is part of a premarket notification filed by Medsurg Industries, Inc. with the FDA for Medsurg 16 Ga. Central Vein Catheterization Tray.
Device ID | K880779 |
510k Number | K880779 |
Device Name: | MEDSURG 16 GA. CENTRAL VEIN CATHETERIZATION TRAY |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
Contact | Tom Bonner |
Correspondent | Tom Bonner MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
Product Code | DWF |
CFR Regulation Number | 870.4210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-26 |
Decision Date | 1988-05-09 |