FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
MEDELA SINGLE USE SILC CUP, MODEL 077.0791
K Number: K041579
·
Decision Apr 21, 2005
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
29
Applicant Total
30
Review Days
311
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Basic Information
- Device Name
- MEDELA SINGLE USE SILC CUP, MODEL 077.0791
- K Number
- K041579
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4340
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medela AG
- Date Received
- June 14, 2004
- Decision Date
- April 21, 2005
- Product Code
- HDB
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HDB | Extractor, Vacuum, Fetal | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HDB), ordered by most recent decision date.
Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)
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FDA Class 2
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FDA Class 2
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MITYVAC MERLIN, MODEL 10027
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SWIFT LOW PROFILE CUP (PRO CUP)
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MITYVAC
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
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