DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET
FDA 510(k) clearance K850255 · decided 1985-05-01
Clearance details
- K-number
- K850255
- Device name
- DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET
- Applicant
- Dow Corning Corp. Healthcare Industries Materials
- Decision
- Substantially Equivalent
- Date received
- 1985-01-22
- Decision date
- 1985-05-01
- Days to decision
- 99 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Hemlock, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Dow Corning Corp. Healthcare Industries Materials
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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| THE SOFT RINSE SYSTEM (P800060/S007) | Dow Corning Corp. Healthcare Industries Materials | 1991-03-05 |
| SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S010) | Dow Corning Corp. Healthcare Industries Materials | 1985-11-18 |
| SILSOFT (ELASTOFILCON A ) CONTACT LENS (P800020/S007) | Dow Corning Corp. Healthcare Industries Materials | 1985-11-05 |
| THE SOFT RINSE SYSTEM (P800060/S006) | Dow Corning Corp. Healthcare Industries Materials | 1985-07-30 |
| SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S008) | Dow Corning Corp. Healthcare Industries Materials | 1984-10-31 |
| THE SOFT RINSE SYSTEM (P800060/S005) | Dow Corning Corp. Healthcare Industries Materials | 1984-04-04 |
| SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S009) | Dow Corning Corp. Healthcare Industries Materials | 1984-03-12 |
| SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S004) | Dow Corning Corp. Healthcare Industries Materials | 1983-11-09 |