The following data is part of a premarket notification filed by Vascular Products, Inc. with the FDA for Sterile Chest Tube.
Device ID | K913733 |
510k Number | K913733 |
Device Name: | STERILE CHEST TUBE |
Classification | Catheter, Peritoneal |
Applicant | VASCULAR PRODUCTS, INC. P.O. BOX 2010 Palm Harbor, FL 34682 |
Contact | Patrick J Lamb |
Correspondent | Patrick J Lamb VASCULAR PRODUCTS, INC. P.O. BOX 2010 Palm Harbor, FL 34682 |
Product Code | GBW |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-20 |
Decision Date | 1991-10-08 |