TOTAL CONTAINMENT DEVICE
System, Dialysate Delivery, Semi-automatic, Peritoneal
DENCO
The following data is part of a premarket notification filed by Denco with the FDA for Total Containment Device.
Pre-market Notification Details
| Device ID | K913515 |
| 510k Number | K913515 |
| Device Name: | TOTAL CONTAINMENT DEVICE |
| Classification | System, Dialysate Delivery, Semi-automatic, Peritoneal |
| Applicant | DENCO P.O. BOX 9600 Wilmington, DE 19809 |
| Contact | Spencer |
| Correspondent | Spencer DENCO P.O. BOX 9600 Wilmington, DE 19809 |
| Product Code | KPF |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-07 |
| Decision Date | 1994-05-26 |
Trademark Results [TOTAL CONTAINMENT DEVICE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TOTAL CONTAINMENT DEVICE 75823845 2445898 Live/Registered |
GENESIS BPS, LLC 1999-10-15 |
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