MEDELA SINGLE USE SILC CUP, MODEL 077.0791
FDA 510(k) clearance K041579 · decided 2005-04-21
Clearance details
- K-number
- K041579
- Device name
- MEDELA SINGLE USE SILC CUP, MODEL 077.0791
- Applicant
- Medela AG
- Decision
- Substantially Equivalent
- Date received
- 2004-06-14
- Decision date
- 2005-04-21
- Days to decision
- 311 days
- Clearance type
- Traditional
- Product code
- HDB
- Device class
- 2
- Regulation number
- 884.4340
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Baar Zug, CH
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.