The following data is part of a premarket notification filed by Medical Engineering And Development Institute with the FDA for Byrd Dilator Sheath Set - Teflon.
| Device ID | K902469 |
| 510k Number | K902469 |
| Device Name: | BYRD DILATOR SHEATH SET - TEFLON |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| 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 | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-04 |
| Decision Date | 1990-08-23 |