SILCLEAR TUBING— 510(k) K943992
Substantially EquivalentDegania Silicone , Ltd.
FDA 510(k) clearance K943992 for SILCLEAR TUBING, Substantially Equivalent on 1995-03-16. Applicant: Degania Silicone , Ltd.. Device class: 2.
Clearance details
- Applicant
- Degania Silicone , Ltd.
- Product code
- Code FPK
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Emek Hayarden, IL
Recent devices under product code FPK
view all- K131517 — MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING
- K063114 — DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES
- K063239 — LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526
- K052431 — MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1
- K041178 — EMPOWER TRANSFER SET, (CAT. NO. 7725)
More clearances from Degania Silicone , Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.