The following data is part of a premarket notification filed by Med Institute, Inc. with the FDA for Byrd Telescoping Stainless Steel Dilat Sheath Set.
| Device ID | K922354 |
| 510k Number | K922354 |
| Device Name: | BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET |
| Classification | Dilator, Catheter |
| Applicant | MED INSTITUTE, INC. P.O. BOX 2402 West Lafayette, IN 47906 |
| Contact | Neal E Fearnot |
| Correspondent | Neal E Fearnot MED INSTITUTE, INC. P.O. BOX 2402 West Lafayette, IN 47906 |
| Product Code | GCC |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-19 |
| Decision Date | 1992-07-30 |