The following data is part of a premarket notification filed by Manan Medical Products, Inc. with the FDA for Manan V.s. Access Needle/set.
| Device ID | K963767 |
| 510k Number | K963767 |
| Device Name: | MANAN V.S. ACCESS NEEDLE/SET |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. Northbrook, IL 60062 |
| Contact | Michael Plishka |
| Correspondent | Michael Plishka MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. Northbrook, IL 60062 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-19 |
| Decision Date | 1997-05-16 |