The following data is part of a premarket notification filed by Akcess Medical Products, Inc. with the FDA for S-100 Allen-brown Shunt.
| Device ID | K892663 |
| 510k Number | K892663 |
| Device Name: | S-100 ALLEN-BROWN SHUNT |
| Classification | Cannula, A-v Shunt |
| 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 | FIQ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-13 |
| Decision Date | 1989-05-04 |