The following data is part of a premarket notification filed by Manan Medical Products, Inc. with the FDA for Manan Pediatric Bone Marrow Access Needle.
| Device ID | K962001 |
| 510k Number | K962001 |
| Device Name: | MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| 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 | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-22 |
| Decision Date | 1997-01-10 |