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
28
Applicant Total
19
Review Days
311
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 |
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FDA 510(k)
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|---|---|---|---|
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| K141926 | INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM | Dec 19, 2014 | Substantially Equivalent |
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| K130123 | BASIC AND DOMINANT FLEX SUCTION PUMPS | Oct 11, 2013 | Substantially Equivalent |
| K130210 | MEDELA THOPAZ | Mar 15, 2013 | Substantially Equivalent |
| K113678 | INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM | Oct 1, 2012 | Substantially Equivalent |
| K080357 | MEDELA INVIA WOUND THERAPY | Jul 24, 2008 | Substantially Equivalent |