Device Type ID | 4298 |
Device Name | Implant, Absorbable, (scleral Buckling Methods) |
Regulation Description | Absorbable Implant (scleral Buckling Method). |
Regulation Medical Specialty | Ophthalmic |
Review Panel | Ophthalmic |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Intraocular And Corneal Implants Devices Branch (ICIB) |
Submission Type | 510(k) |
CFR Regulation Number | 886.3300 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | HQJ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4298 |
Device | Implant, Absorbable, (scleral Buckling Methods) |
Product Code | HQJ |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Absorbable Implant (scleral Buckling Method). |
CFR Regulation Number | 886.3300 [🔎] |