The following data is part of a premarket notification filed by Medsurg Industries, Inc. with the FDA for Medsurg 7 Fr. Dual Lumen Central Vein Cath System.
Device ID | K880771 |
510k Number | K880771 |
Device Name: | MEDSURG 7 FR. DUAL LUMEN CENTRAL VEIN CATH SYSTEM |
Classification | Cannula, Catheter |
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 | DQR |
CFR Regulation Number | 870.1300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-26 |
Decision Date | 1988-05-03 |