The following data is part of a premarket notification filed by Akcess Medical Products, Inc. with the FDA for Dual Lumen Sub-clavian Cath Kit, Dlsc 600k & 800k.
| Device ID | K891755 |
| 510k Number | K891755 |
| Device Name: | DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K |
| Classification | Catheter, Subclavian |
| Applicant | AKCESS MEDICAL PRODUCTS, INC. 789 JERSEY AVE. New Brunswick, NJ 08901 |
| Contact | Edward J Hopkins |
| Correspondent | Edward J Hopkins AKCESS MEDICAL PRODUCTS, INC. 789 JERSEY AVE. New Brunswick, NJ 08901 |
| Product Code | LFJ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-23 |
| Decision Date | 1989-06-08 |