RS OPTIGUARD GOWN & DRAPE MATERIAL— 510(k) K925715
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K925715 for RS OPTIGUARD GOWN & DRAPE MATERIAL, Substantially Equivalent on 1993-05-11. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code FYA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukegan, IL, US
Recent devices under product code FYA
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Data sourced from openFDA. This site is unofficial and independent of the FDA.