MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK
FDA 510(k) clearance K831773 · decided 1983-08-16
Clearance details
- K-number
- K831773
- Device name
- MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK
- Applicant
- Bcd Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-06-02
- Decision date
- 1983-08-16
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- HQJ
- Device class
- 2
- Regulation number
- 886.3300
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TITAN AIR SPECTACLE FRAME (K896350) | Acces Intl. Eyewear | 1989-12-18 |
| LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD (K884362) | Bausch & Lomb Pharmaceutical, Inc. | 1988-11-29 |
| LABTICIAN RETINAL IMPLANTS (K875014) | Labtician Products, Inc. | 1988-02-26 |
| IMPLANT, SILICONE AND TANTALUM (K760550) | Medical Instrument Research Assoc., Inc. | 1976-10-05 |
Recalls involving this device
No recalls on record reference this clearance.