The following data is part of a premarket notification filed by Med Institute, Inc. with the FDA for Non-coring Needle.
| Device ID | K960698 |
| 510k Number | K960698 |
| Device Name: | NON-CORING NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MED INSTITUTE, INC. P.O. BOX 2402 West Lafayette, IN 47906 |
| Contact | Neal E Fearnot, Ph.d., E.e. |
| Correspondent | Neal E Fearnot, Ph.d., E.e. MED INSTITUTE, INC. P.O. BOX 2402 West Lafayette, IN 47906 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-20 |
| Decision Date | 1996-04-15 |
| Summary: | summary |