The following data is part of a premarket notification filed by Bcd Products, Inc. with the FDA for Mai Hydroseal Implant For Scleral Buck.
| Device ID | K831773 |
| 510k Number | K831773 |
| Device Name: | MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK |
| Classification | Implant, Absorbable, (scleral Buckling Methods) |
| Applicant | BCD PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HQJ |
| CFR Regulation Number | 886.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-02 |
| Decision Date | 1983-08-16 |