BCM DRY PACK BICARBONATE MIXER
FDA 510(k) clearance K873166 · decided 1987-12-30
Clearance details
- K-number
- K873166
- Device name
- BCM DRY PACK BICARBONATE MIXER
- Applicant
- Specialty Dialysis Services
- Decision
- Substantially Equivalent
- Date received
- 1987-08-11
- Decision date
- 1987-12-30
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- FIN
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Tempe, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.