DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT— 510(k) K072930
Substantially EquivalentDemetech Corp.
FDA 510(k) clearance K072930 for DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT, Substantially Equivalent on 2008-04-30. Applicant: Demetech Corp.. Device class: 2.
Clearance details
- Applicant
- Demetech Corp.
- Product code
- Code GAL
- Device class
- Class 2
- Regulation
- 21 CFR 878.4830
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
Recent devices under product code GAL
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- K082097 — DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE
- K043330 — POLYPROPILENE SURGICAL SUTURES
Adverse events under product code GAL
product code GAL- Malfunction
- 681
- Other
- 1
- Total
- 682
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.