The following data is part of a premarket notification filed by National Medical Care, Medical Products Div., Inc. with the FDA for Catheter Adapter Sealing Cap No. 48-1028-9.
Device ID | K900006 |
510k Number | K900006 |
Device Name: | CATHETER ADAPTER SEALING CAP NO. 48-1028-9 |
Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
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 | KDJ |
CFR Regulation Number | 876.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-02 |
Decision Date | 1990-02-27 |