UNISILK
FDA 510(k) clearance K042282 · decided 2004-12-01
Clearance details
- K-number
- K042282
- Device name
- UNISILK
- Applicant
- United Medical Industries Co. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-08-24
- Decision date
- 2004-12-01
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- GAP
- Device class
- 2
- Regulation number
- 878.5030
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Riyadh, Central Province, SA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.