The following data is part of a premarket notification filed by Grand Medical Products with the FDA for Central Line Dressing Change Tray, Tpn/cvp Dressing Change Tray.
| Device ID | K963719 |
| 510k Number | K963719 |
| Device Name: | CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY |
| Classification | Wound Dressing Kit |
| Applicant | GRAND MEDICAL PRODUCTS 1300 REMINGTON ROAD, SUITE K Schaumburg, IL 60173 |
| Contact | Harvey Weiss |
| Correspondent | Harvey Weiss GRAND MEDICAL PRODUCTS 1300 REMINGTON ROAD, SUITE K Schaumburg, IL 60173 |
| Product Code | MCY |
| CFR Regulation Number | 880.5075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-16 |
| Decision Date | 1996-11-27 |