The following data is part of a premarket notification filed by Akcess Medical Products, Inc. with the FDA for Tenckhoff Peritoneal Dialysis Kit.
| Device ID | K902203 |
| 510k Number | K902203 |
| Device Name: | TENCKHOFF PERITONEAL DIALYSIS KIT |
| Classification | Dialyzer, Parallel Flow |
| Applicant | AKCESS MEDICAL PRODUCTS, INC. 789 JERSEY AVE. New Brunswick, NJ 08901 |
| Contact | Balbir Kapany |
| Correspondent | Balbir Kapany AKCESS MEDICAL PRODUCTS, INC. 789 JERSEY AVE. New Brunswick, NJ 08901 |
| Product Code | FJG |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-16 |
| Decision Date | 1990-08-01 |