The following data is part of a premarket notification filed by Akcess Medical Products, Inc. with the FDA for Silicone Catheter Repair Kits.
| Device ID | K926374 |
| 510k Number | K926374 |
| Device Name: | SILICONE CATHETER REPAIR KITS |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | AKCESS MEDICAL PRODUCTS, INC. 201 NORTH CENTER DR. New Brunswick, NJ 08902 |
| Contact | Balbir Kapany |
| Correspondent | Balbir Kapany AKCESS MEDICAL PRODUCTS, INC. 201 NORTH CENTER DR. New Brunswick, NJ 08902 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-22 |
| Decision Date | 1994-10-07 |