THE DOUBLE GLOVE— 510(k) K060030
Substantially EquivalentBiobarrier, Inc.
FDA 510(k) clearance K060030 for THE DOUBLE GLOVE, Substantially Equivalent on 2006-06-27. Applicant: Biobarrier, Inc.. Device class: 1.
Clearance details
- Applicant
- Biobarrier, Inc.
- 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
- Traditional
- Location
- Good Hope, GA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.