REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE— 510(k) K980942
Substantially EquivalentLondon International Group, Inc.
FDA 510(k) clearance K980942 for REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE, Substantially Equivalent on 1998-05-11. Applicant: London International Group, Inc.. Device class: 1.
Clearance details
- Applicant
- London International Group, 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
- Dotham, AL, US
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