TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N— 510(k) K061308
Substantially EquivalentCardinal Health 200, Inc.
FDA 510(k) clearance K061308 for TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N, Substantially Equivalent on 2006-06-05. Applicant: Cardinal Health 200, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardinal Health 200, Inc.
- 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
- Special
- Location
- Waukegan, IL, US
Recent devices under product code FYA
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- K261028 — Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)
- K261949 — NYES Tuff Cuff L3 Disposable Gowns
- K252575 — Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
- K260725 — BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
More clearances from Cardinal Health 200, Inc.
view allRecalls naming K061308
K-number listed on FDA's recall record- Z-1002-2020 — AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA
- Z-1004-2020 — AAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NB
- Z-1005-2020 — AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA
- Z-1006-2020 — AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
- Z-1008-2020 — AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
- Z-1017-2020 — AAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NA
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061308.
Data sourced from openFDA. This site is unofficial and independent of the FDA.