The following data is part of a premarket notification filed by National Medical Care, Medical Products Div., Inc. with the FDA for Combilines Hemodialysis Blood Tubing Set.
| Device ID | K962081 |
| 510k Number | K962081 |
| Device Name: | COMBILINES HEMODIALYSIS BLOOD TUBING SET |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. 2 VOLVO DR. Rockleigh, NJ 07647 |
| Contact | Debra L Bing |
| Correspondent | Debra L Bing NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. 2 VOLVO DR. Rockleigh, NJ 07647 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-28 |
| Decision Date | 1996-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840861100535 | K962081 | 000 |
| 10840861100528 | K962081 | 000 |
| 10840861100306 | K962081 | 000 |
| 10840861100290 | K962081 | 000 |
| 10840861100252 | K962081 | 000 |
| 10840861100245 | K962081 | 000 |
| 10840861100238 | K962081 | 000 |
| 10840861100221 | K962081 | 000 |