The following data is part of a premarket notification filed by Medical Specialties Intl., Inc. with the FDA for Sedratrol.
| Device ID | K940430 |
| 510k Number | K940430 |
| Device Name: | SEDRATROL |
| Classification | Control, Red-cell |
| Applicant | MEDICAL SPECIALTIES INTL., INC. 3610 KENNEDY RD. South Plainfield, NJ 07080 |
| Contact | W. Kevin Liddle |
| Correspondent | W. Kevin Liddle MEDICAL SPECIALTIES INTL., INC. 3610 KENNEDY RD. South Plainfield, NJ 07080 |
| Product Code | GJR |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-31 |
| Decision Date | 1995-02-06 |