The following data is part of a premarket notification filed by Manan Medical Products, Inc. with the FDA for Manan Huber Style Infusion Needle.
| Device ID | K883744 |
| 510k Number | K883744 |
| Device Name: | MANAN HUBER STYLE INFUSION NEEDLE |
| Classification | Syringe, Piston |
| Applicant | MANAN MEDICAL PRODUCTS, INC. 8020 NORTH CENTRAL PARK AVE. Skokie, IL 60076 |
| Contact | Manfred Mittermeier |
| Correspondent | Manfred Mittermeier MANAN MEDICAL PRODUCTS, INC. 8020 NORTH CENTRAL PARK AVE. Skokie, IL 60076 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-01 |
| Decision Date | 1988-09-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20859013006073 | K883744 | 000 |