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 |