The following data is part of a premarket notification filed by Sun Medical, Inc. with the FDA for Sun Medical Laminaria Cervical Dilator.
| Device ID | K845006 |
| 510k Number | K845006 |
| Device Name: | SUN MEDICAL LAMINARIA CERVICAL DILATOR |
| Classification | Dilator, Cervical, Hygroscopic-laminaria |
| Applicant | SUN MEDICAL, INC. 1179 CORPORATE DR. WEST, #100 Arlington, TX 76006 |
| Contact | Howard Penney |
| Correspondent | Howard Penney SUN MEDICAL, INC. 1179 CORPORATE DR. WEST, #100 Arlington, TX 76006 |
| Product Code | HDY |
| CFR Regulation Number | 884.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-26 |
| Decision Date | 1985-05-01 |