EPISCLERAL VENOUS PRESSURE
FDA 510(k) clearance K843354 · decided 1984-11-19
Clearance details
- K-number
- K843354
- Device name
- EPISCLERAL VENOUS PRESSURE
- Applicant
- Eyetech, LLC
- Decision
- Substantially Equivalent
- Date received
- 1984-08-27
- Decision date
- 1984-11-19
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- HKX
- Device class
- 2
- Regulation number
- 886.1930
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CHANGE IN MANUFACTURING PROCESS TO CLEAN EYE (P880082/S018) | Eyetech, LLC | 1995-09-28 |
| ACCUTECH SINGLE & THREE PIECE INTRAOCULAR LENSES (P880082/S017) | Eyetech, LLC | 1994-10-04 |
| MODIFIED LABELING FOR IOL 60 MOS.STERILITY EXPIR. (P880082/S014) | Eyetech, LLC | 1992-05-15 |
| TIER A MODELS 24050,24150,25050,25350-125 LENSES (P880082/S012) | Eyetech, LLC | 1991-09-04 |
| TIER A MODELS 24050,24150,25050,25350-125 LENSES (P880082/S013) | Eyetech, LLC | 1991-08-06 |
| THREE & SINGLE PIECE BIOCONVEX INTRAOCULAR LENSES (P880082/S009) | Eyetech, LLC | 1991-07-23 |
| INTRAOCULAR LENSES (P880082/S011) | Eyetech, LLC | 1991-05-01 |
| MODEL 14760 UV ABSORBING POSTERIOR CHAMBER LENSES (P880082/S003) | Eyetech, LLC | 1990-09-14 |