VYDAX 525-550 & 5100 FLUOROTELOMER— 510(k) K833357
Substantially EquivalentETHICON, Inc.
FDA 510(k) clearance K833357 for VYDAX 525-550 & 5100 FLUOROTELOMER, Substantially Equivalent on 1983-12-12. Applicant: ETHICON, Inc.. Device class: 1.
Clearance details
- Applicant
- ETHICON, Inc.
- Product code
- Code GDT
- Device class
- Class 1
- Regulation
- 21 CFR 878.4760
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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Adverse events under product code GDT
product code GDT- Malfunction
- 752
- Total
- 752
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.