TITANIUM PEG SYSTEM
FDA 510(k) clearance K980822 · decided 1998-07-09
Clearance details
- K-number
- K980822
- Device name
- TITANIUM PEG SYSTEM
- Applicant
- Fci Ophthalmics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-03-03
- Decision date
- 1998-07-09
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- MQU
- Device class
- 2
- Regulation number
- 886.3320
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Marshfield Hills, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Fci Ophthalmics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE (K000151) | Integrated Orbital Implants, Inc. | 2000-04-10 |
| PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM (K974203) | Integrated Orbital Implants, Inc. | 1998-02-04 |
| MEDPOR OCULAR SCREW AND ACCEOSSORIES (K971583) | Porex Technologies Corp. | 1997-06-30 |
Recalls involving this device
No recalls on record reference this clearance.