METRO 55G TORIC & SPHERICAL
FDA 510(k) clearance K953199 · decided 1995-12-11
Clearance details
- K-number
- K953199
- Device name
- METRO 55G TORIC & SPHERICAL
- Applicant
- Metrosoft, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-07-10
- Decision date
- 1995-12-11
- Days to decision
- 154 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Rosewell, GA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Metrosoft
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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT (P820026/S008) | Metrosoft, Inc. | 1990-09-17 |
| METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT (P820026/S007) | Metrosoft, Inc. | 1990-01-31 |
| METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT (P820026/S006) | Metrosoft, Inc. | 1989-10-13 |
| METRO 55 (METHAFILCON A) (P830077/S002) | Metrosoft, Inc. | 1989-03-02 |
| METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT (P820026/S005) | Metrosoft, Inc. | 1989-03-01 |
| METRO 55 (METHAFILCON A) (P830077/S001) | Metrosoft, Inc. | 1989-02-21 |
| METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT (P820026/S003) | Metrosoft, Inc. | 1989-02-21 |
| METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT (P820026/S004) | Metrosoft, Inc. | 1988-11-10 |