Atlas FDA

WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733

FDA 510(k) clearance K000628 · decided 2000-03-13

Clearance details

K-number
K000628
Device name
WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733
Applicant
Sims Portex , Ltd.
Decision
Substantially Equivalent
Date received
2000-02-24
Decision date
2000-03-13
Days to decision
18 days
Clearance type
Traditional
Product code
MQE
Device class
2
Regulation number
884.6100
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Hythe, Kent, GB
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Wallace Oocyte Recovery Needles,Oocyte Recovery sets, 750 mm tube with flushing connector, recall (Z-0593-2009)Irvine Scientific Sales Co Inc2008-12-22