SILASTIC SOFT SHEETING
FDA 510(k) clearance K894226 · decided 1990-01-03
Clearance details
- K-number
- K894226
- Device name
- SILASTIC SOFT SHEETING
- Applicant
- Dow Corning Wright
- Decision
- Substantially Equivalent
- Date received
- 1989-06-19
- Decision date
- 1990-01-03
- Days to decision
- 198 days
- Clearance type
- Traditional
- Product code
- FRO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Arlington, TN, US
- Third-party review
- No
- Expedited review
- No
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| New Day Skin Spray (K252568) | Silk Holdings, Inc. | 2026-01-23 |
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS (P880076/S001) | Dow Corning Wright | 1991-06-17 |