BIOGEL PL MICRO SURGICAL GLOVE— 510(k) K141719
Substantially EquivalentMolnlycke Health Care Us, LLC
FDA 510(k) clearance K141719 for BIOGEL PL MICRO SURGICAL GLOVE, Substantially Equivalent on 2014-09-04. Applicant: Molnlycke Health Care Us, LLC. Device class: 1.
Clearance details
- Applicant
- Molnlycke Health Care Us, LLC
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Norcross, GA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.