510(k) K023930
- Device
- COOPERSURGICAL OOCYTE RECOVERY NEEDLES
- Applicant
- COOPERSURGICAL, INC.
- 510(k) number
- K023930
- Product code
- MQE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-01-22
- Date received
- 2002-11-25
- Regulation
- 884.6100
- Classification name
- Needle, Assisted Reproduction
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- JOSEPH M AZARY
- Address
- P.O. Box 2156 Huntington CT US 06484 06484
FDA Registration Numbers
- 3009756327
- 3015136743
- 3003775072
- 1450908
- 3014755376
- 3003995932
- 9610632
- 3014295858
- 9617744
- 3034286426
- 3008876063
- 3005580113
- 9612445
- 1216677
- 3010155661
- 3006405073
- 3017896194
- 3009217531
- 3005136445
- 8043478
- 3008456389
- 1650907
- 9680654
- 1820334
- 3005987240
- 9611680
- 3015140190
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Legacy Summary
summary
FDA Review
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