COBE SYSTEM 3
FDA 510(k) clearance K851306 · decided 1985-06-12
Clearance details
- K-number
- K851306
- Device name
- COBE SYSTEM 3
- Applicant
- Cobe Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-04-01
- Decision date
- 1985-06-12
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- FKP
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lakewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.