SMITH & NEPHEW DAYLIGHTER(TM)— 510(k) K873786
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K873786 for SMITH & NEPHEW DAYLIGHTER(TM), Substantially Equivalent on 1987-10-23. Applicant: Smith & Nephew, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- Code FSY
- Device class
- Class 2
- Regulation
- 21 CFR 878.4580
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
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Adverse events under product code FSY
product code FSY- Malfunction
- 2,759
- Other
- 1
- Total
- 2,760
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.