BARRIER SURGICAL DRAPES— 510(k) K051625
Substantially EquivalentMolnlycke Health Care, Inc.
FDA 510(k) clearance K051625 for BARRIER SURGICAL DRAPES, Substantially Equivalent on 2005-07-14. Applicant: Molnlycke Health Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Molnlycke Health Care, Inc.
- Product code
- Code KKX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4370
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Newtown, PA, US
Recent devices under product code KKX
view allMore clearances from Molnlycke Health Care, Inc.
view all- K062138 — POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE
- K000902 — KLINIDRAPE REINFORCED SURGICAL GOWNS
- 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.