The following data is part of a premarket notification filed by Medical Engineering And Development Institute with the FDA for Locking Wire Guide Stylet.
| Device ID | K890820 |
| 510k Number | K890820 |
| Device Name: | LOCKING WIRE GUIDE STYLET |
| Classification | Retractor |
| Applicant | MEDICAL ENGINEERING AND DEVELOPMENT INSTITUTE P.O. BOX 2402 West Lafayette, IN 47906 |
| Contact | Fearnot, Phd |
| Correspondent | Fearnot, Phd MEDICAL ENGINEERING AND DEVELOPMENT INSTITUTE P.O. BOX 2402 West Lafayette, IN 47906 |
| Product Code | GAD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-17 |
| Decision Date | 1989-03-22 |