The following data is part of a premarket notification filed by Akcess Medical Products, Inc. with the FDA for Da-46 Fluid Barrier.
| Device ID | K891752 |
| 510k Number | K891752 |
| Device Name: | DA-46 FLUID BARRIER |
| Classification | Protector, Transducer, Dialysis |
| 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 | FIB |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-23 |
| Decision Date | 1989-04-07 |