SPLASH SHIELD # 4505, 4507, PARASHIELD # 4509— 510(k) K922716
Substantially EquivalentSplash Shield, Inc.
FDA 510(k) clearance K922716 for SPLASH SHIELD # 4505, 4507, PARASHIELD # 4509, Substantially Equivalent on 1992-10-23. Applicant: Splash Shield, Inc.. Device class: 2.
Clearance details
- Applicant
- Splash Shield, Inc.
- Product code
- Code FXX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Woburn, MA, US
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Adverse events under product code FXX
product code FXX- Injury
- 137
- Total
- 137
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.