510(k) K831773
- Device
- MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK
- Applicant
- BCD PRODUCTS, INC.
- 510(k) number
- K831773
- Product code
- HQJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-08-16
- Date received
- 1983-06-02
- Regulation
- 886.3300
- Classification name
- Implant, Absorbable, (scleral Buckling Methods)
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 2025182
- 1220477
- 1218813
- 9611665
- 9612327
- 3011481350
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HQJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K896350 | TITAN AIR SPECTACLE FRAME | Acces Intl. Eyewear | 1989-12-18 |
| K884362 | LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD | Bausch & Lomb Pharmaceutical, Inc. | 1988-11-29 |
| K875014 | LABTICIAN RETINAL IMPLANTS | Labtician Products, Inc. | 1988-02-26 |
| K760550 | IMPLANT, SILICONE AND TANTALUM | Medical Instrument Research Assoc., Inc. | 1976-10-05 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases