REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVE— 510(k) K970924
Substantially EquivalentRegent Medical
FDA 510(k) clearance K970924 for REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVE, Substantially Equivalent on 1997-04-01. Applicant: Regent Medical. Device class: 1.
Clearance details
- Applicant
- Regent Medical
- 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
- Dothan, AL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.