SUTURES POLYPROP., POLYETHELINE, NYLON & SILK— 510(k) K930739
Substantially EquivalentDeknatel, Inc.
FDA 510(k) clearance K930739 for SUTURES POLYPROP., POLYETHELINE, NYLON & SILK, Substantially Equivalent on 1994-07-26. Applicant: Deknatel, Inc.. Device class: 2.
Clearance details
- Applicant
- Deknatel, Inc.
- Product code
- Code GAP
- Device class
- Class 2
- Regulation
- 21 CFR 878.5030
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose-Heredia, CR
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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 GAP
product code GAP- Death
- 3
- Injury
- 491
- Malfunction
- 2,253
- Total
- 2,747
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.