DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)— 510(k) K031408
Substantially EquivalentDeroyal
FDA 510(k) clearance K031408 for DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE), Substantially Equivalent on 2003-10-15. Applicant: Deroyal. Device class: 2.
Clearance details
- Applicant
- Deroyal
- 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
- Powell, TN, US
Recent devices under product code FYA
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- K260725 — BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
More clearances from Deroyal
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