WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS— 510(k) K031622
Substantially EquivalentPortex , Ltd.
FDA 510(k) clearance K031622 for WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS, Substantially Equivalent on 2003-06-26. Applicant: Portex , Ltd.. Device class: 2.
Clearance details
- Applicant
- Portex , Ltd.
- Product code
- Code MQE
- Device class
- Class 2
- Regulation
- 21 CFR 884.6100
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- England Ct21 6db, GB
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More clearances from Portex , Ltd.
view all- K040014 — PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY
- K032112 — P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)
- K033084 — WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER
- K032716 — PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE)
- K030570 — BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
Data sourced from openFDA. This site is unofficial and independent of the FDA.