510(k) K896350
- Device
- TITAN AIR SPECTACLE FRAME
- Applicant
- ACCES INTL. EYEWEAR
- 510(k) number
- K896350
- Product code
- HQJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-12-18
- Date received
- 1989-11-06
- 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#
- Contact
- STEPHAN LAUDICINO
- Address
- 444 Bunker Rd. West Palm Beach FL US 33405 33405
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 |
|---|---|---|---|
| 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 |
| K831773 | MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK | Bcd Products, Inc. | 1983-08-16 |
| K760550 | IMPLANT, SILICONE AND TANTALUM | Medical Instrument Research Assoc., Inc. | 1976-10-05 |
Legacy Summary#
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FDA Review#
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