| Device Type ID | 3898 |
| Device Name | Dilator, Cervical, Hygroscopic-laminaria |
| Regulation Description | Hygroscopic Laminaria Cervical Dilator. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 884.4260 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HDY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 3898 |
| Device | Dilator, Cervical, Hygroscopic-laminaria |
| Product Code | HDY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hygroscopic Laminaria Cervical Dilator. |
| CFR Regulation Number | 884.4260 [🔎] |
| Device Problems | |
|---|---|
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 5 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 6 |