KLINIDRAPE REINFORCED SURGICAL GOWNS— 510(k) K000902
Substantially EquivalentMolnlycke Health Care, Inc.
FDA 510(k) clearance K000902 for KLINIDRAPE REINFORCED SURGICAL GOWNS, Substantially Equivalent on 2000-07-11. Applicant: Molnlycke Health Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Molnlycke Health Care, 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
- Traditional
- Location
- Eddystone, PA, US
Recent devices under product code FYA
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- 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 Molnlycke Health Care, Inc.
view all- K062138 — POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE
- K051625 — BARRIER SURGICAL DRAPES
- K000901 — KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION
- K000906 — KLINIDRAPE SURGICAL DRAPES
- K984371 — MEPITEL NON ADHERENT SILICONE DRESSING
Data sourced from openFDA. This site is unofficial and independent of the FDA.