SILASTIC BRAND PERCUTANEOUS SKIN EXPANDE
FDA 510(k) clearance K801042 · decided 1980-06-26
Clearance details
- K-number
- K801042
- Device name
- SILASTIC BRAND PERCUTANEOUS SKIN EXPANDE
- Applicant
- Dow Corning Corp. Healthcare Industries Materials
- Decision
- Substantially Equivalent
- Date received
- 1980-05-02
- Decision date
- 1980-06-26
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- LCJ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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| AlloX2 Pro Tissue Expanders (K214124) | Sientra, Inc. | 2023-06-08 |
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| CPX 4 Breast Tissue Expander with Smooth Surface (K182335) | Mentor Worldwide, LLC | 2018-09-25 |
| Natrelle 133S Tissue Expander (K182054) | Allergan | 2018-08-29 |
| Unger Quad Injector (K161483) | Stradis Healthcare | 2016-10-31 |
| ARTOURA Breast Tissue Expanders with Smooth Surface (K161176) | Mentor Worldwide, LLC | 2016-05-23 |
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 |