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 |