510(k) K980822
- Device
- TITANIUM PEG SYSTEM
- Applicant
- FCI OPHTHALMICS, INC.
- 510(k) number
- K980822
- Product code
- MQU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-07-09
- Date received
- 1998-03-03
- Regulation
- 886.3320
- Classification name
- Ocular Peg
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANNE BOHSACK
- Address
- P.O. Box 465 76 Prospect St. Marshfield Hills MA US 02051 02051
FDA Registration Numbers#
- 8010177
- 2027377
- 9615745
- 3004467263
- 3002991496
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MQU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K000151 | PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE | Integrated Orbital Implants, Inc. | 2000-04-10 |
| K974203 | PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM | Integrated Orbital Implants, Inc. | 1998-02-04 |
| K971583 | MEDPOR OCULAR SCREW AND ACCEOSSORIES | Porex Technologies Corp. | 1997-06-30 |
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