BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)— 510(k) K071414
Substantially EquivalentMolnlycke Health Care Us, LLC
FDA 510(k) clearance K071414 for BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS), Substantially Equivalent on 2007-09-10. Applicant: Molnlycke Health Care Us, LLC.
Clearance details
- Applicant
- Molnlycke Health Care Us, LLC
- Product code
- Code KGO
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norcross, GA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.