IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES— 510(k) K905286
Substantially EquivalentInternacional Farmaceutica, S.A. DE C.V.
FDA 510(k) clearance K905286 for IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES, Substantially Equivalent on 1991-02-11. Applicant: Internacional Farmaceutica, S.A. DE C.V.. Device class: 2.
Clearance details
- Applicant
- Internacional Farmaceutica, S.A. DE C.V.
- Product code
- Code GAR
- Device class
- Class 2
- Regulation
- 21 CFR 878.5020
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Great Neck, NY, US
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Adverse events under product code GAR
product code GAR- Injury
- 422
- Malfunction
- 3,386
- Other
- 4
- Total
- 3,812
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.