The following data is part of a premarket notification filed by Akcess Medical Products, Inc. with the FDA for Introducer Needles.
| Device ID | K910641 |
| 510k Number | K910641 |
| Device Name: | INTRODUCER NEEDLES |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | AKCESS MEDICAL PRODUCTS, INC. 789 JERSEY AVE. New Brunswick, NJ 08901 |
| Contact | Balbir B Kapany |
| Correspondent | Balbir B Kapany AKCESS MEDICAL PRODUCTS, INC. 789 JERSEY AVE. New Brunswick, NJ 08901 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-13 |
| Decision Date | 1991-04-29 |