510(k) K000151
- Device
- PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE
- Applicant
- INTEGRATED ORBITAL IMPLANTS, INC.
- 510(k) number
- K000151
- Product code
- MQU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-04-10
- Date received
- 2000-01-19
- 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
- FLOYD G LARSON
- Address
- 4329 Graydon Rd. San Diego CA US 92130 92130
FDA Registration Numbers#
- 8010177
- 2027377
- 9615745
- 3004467263
- 3002991496
Source Documents#
Other 510(k) Records For Product Code MQU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K971583 | MEDPOR OCULAR SCREW AND ACCEOSSORIES | Porex Technologies Corp. | 1997-06-30 |
Legacy Summary#
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FDA Review#
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