K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01— 510(k) K013401
Substantially EquivalentK-Systems, Kivex Biotec , Ltd.
FDA 510(k) clearance K013401 for K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01, Substantially Equivalent on 2001-12-14. Applicant: K-Systems, Kivex Biotec , Ltd.. Device class: 2.
Clearance details
- Applicant
- K-Systems, Kivex Biotec , Ltd.
- Product code
- Code MQG
- Device class
- Class 2
- Regulation
- 21 CFR 884.6120
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Birkerod, DK
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Data sourced from openFDA. This site is unofficial and independent of the FDA.