DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIED— 510(k) K911905
Substantially EquivalentDeknatel, Inc.
FDA 510(k) clearance K911905 for DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIED, Substantially Equivalent on 1991-07-02. Applicant: Deknatel, Inc.. Device class: 2.
Clearance details
- Applicant
- Deknatel, Inc.
- Product code
- Code GAW
- Device class
- Class 2
- Regulation
- 21 CFR 878.5010
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose-Heredia, CR
Recent devices under product code GAW
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- K962856 — PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR
Adverse events under product code GAW
product code GAW- Death
- 66
- Injury
- 1,616
- Malfunction
- 10,428
- Total
- 12,110
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.