MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK
Device Facts
| Record ID | K831773 |
|---|---|
| Device Name | MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK |
| Applicant | Bcd Products, Inc. |
| Product Code | HQJ · Ophthalmic |
| Decision Date | Aug 16, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.3300 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An absorbable implant (scleral buckling method) is a device intended to be implanted on the sclera to aid retinal reattachment.
