BACSTOP
FDA 510(k) clearance K053405 · decided 2006-05-11
Clearance details
- K-number
- K053405
- Device name
- BACSTOP
- Applicant
- Elcam Medical Acal
- Decision
- Substantially Equivalent
- Date received
- 2005-12-07
- Decision date
- 2006-05-11
- Days to decision
- 155 days
- Clearance type
- Traditional
- Product code
- FMG
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mp. Merom Hagalil, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.