The following data is part of a premarket notification filed by National Medical Care, Medical Products Div., Inc. with the FDA for Arterial/venous Bloodlines.
Device ID | K901688 |
510k Number | K901688 |
Device Name: | ARTERIAL/VENOUS BLOODLINES |
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 | John R Trembley |
Correspondent | John R Trembley 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 | 1990-04-12 |
Decision Date | 1990-08-02 |