The following data is part of a premarket notification filed by National Medical Care, Medical Products Div., Inc. with the FDA for Erika Arterial Line 03-9837-0.
| Device ID | K853962 |
| 510k Number | K853962 |
| Device Name: | ERIKA ARTERIAL LINE 03-9837-0 |
| 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 | Del Donna |
| Correspondent | Del Donna 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 | 1985-09-25 |
| Decision Date | 1985-10-18 |