BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE— 510(k) K000421
Substantially EquivalentSsl Americas, Inc. (Regent Medical)
FDA 510(k) clearance K000421 for BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE, Substantially Equivalent on 2000-08-14. Applicant: Ssl Americas, Inc. (Regent Medical). Device class: 1.
Clearance details
- Applicant
- Ssl Americas, Inc. (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
- Norcross, GA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.