EYE CUP, STERILE 1 AND NON STERILE
FDA 510(k) clearance K051414 · decided 2005-06-16
Clearance details
- K-number
- K051414
- Device name
- EYE CUP, STERILE 1 AND NON STERILE
- Applicant
- Tollot Pty.Ltd.(Aaxis Pacific)
- Decision
- Substantially Equivalent
- Date received
- 2005-05-31
- Decision date
- 2005-06-16
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- LXQ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Littleton, CO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Tollot Pty.Ltd.(Aaxis Pacific)
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 |
|---|---|---|
| Dynarex Eye Cups (K151575) | Dynarex Corporation | 2015-09-01 |
| FLENTS PLASTIC EYE WASH CUP (K140409) | Apothecary Products, Inc. | 2014-07-09 |
| VISTA EYESHOWER (K971134) | John Branch | 1997-11-04 |
| ADVANCE DIAGNOSTICS DISPOSABLE EYECUP (K881369) | Advantage Diagnostics Corp. | 1988-05-13 |
Recalls involving this device
No recalls on record reference this clearance.