The following data is part of a premarket notification filed by National Medical Care, Medical Products Div., Inc. with the FDA for Negative Pressure Arterial Line Cat. No: 03-9630.
| Device ID | K903021 |
| 510k Number | K903021 |
| Device Name: | NEGATIVE PRESSURE ARTERIAL LINE CAT. NO: 03-9630 |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. TWO VOLVO DR. Rockleigh, NJ 07647 |
| Contact | William Mathews |
| Correspondent | William Mathews NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. TWO 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 | 1990-07-11 |
| Decision Date | 1990-08-14 |