BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,
FDA 510(k) clearance K111405 · decided 2012-02-13
Clearance details
- K-number
- K111405
- Device name
- BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,
- Applicant
- Hangzhou Bever Medical Devices Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-05-19
- Decision date
- 2012-02-13
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- GBM
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hangzhou, Zhejiang, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.