510(k) K971583
- Device
- MEDPOR OCULAR SCREW AND ACCEOSSORIES
- Applicant
- POREX TECHNOLOGIES CORP.
- 510(k) number
- K971583
- Product code
- MQU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-06-30
- Date received
- 1997-04-30
- Regulation
- 886.3320
- Classification name
- Ocular Peg
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HOWARD MERCER
- Address
- 500 Bohannon Rd. Fairburn GA US 30213 30213
FDA Registration Numbers#
- 8010177
- 2027377
- 9615745
- 3004467263
- 3002991496
Source Documents#
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 |
| K980822 | TITANIUM PEG SYSTEM | Fci Ophthalmics, Inc. | 1998-07-09 |
| K974203 | PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM | Integrated Orbital Implants, Inc. | 1998-02-04 |
Legacy Summary#
summary
FDA Review#
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