510(k) K013401
- Device
- K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01
- Applicant
- K-Systems, Kivex Biotec , Ltd.
- 510(k) number
- K013401
- Product code
- MQG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-12-14
- Date received
- 2001-10-15
- Regulation
- 884.6120
- Classification name
- Accessory, Assisted Reproduction
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- JACOB MOLLENBACH
- Address
- Klintehoj Vaenge 21 Birkerod DK DA-3460 DA-3460
FDA Registration Numbers
- 1825146
- 3008157119
- 3023235140
- 3009107689
- 3003775072
- 3034431159
- 1221433
- 1523845
- 9617472
- 9613662
- 9610632
- 1066270
- 3005580113
- 1216677
- 3006405073
- 3017247483
- 3004871219
- 1222779
- 9680654
- 3009747883
- 1000393132
- 1820334
- 3012853704
- 3003244268
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON
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