ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN— 510(k) K982058
Substantially EquivalentEncompass Group, LLC
FDA 510(k) clearance K982058 for ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN, Substantially Equivalent on 1999-01-14. Applicant: Encompass Group, LLC. Device class: 2.
Clearance details
- Applicant
- Encompass Group, LLC
- 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
- Mcdonough, GA, US
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More clearances from Encompass Group, LLC
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