DOUBLE ELUTRA-PACK UNIT
FDA 510(k) clearance K760914 · decided 1976-11-23
Clearance details
- K-number
- K760914
- Device name
- DOUBLE ELUTRA-PACK UNIT
- Applicant
- Travenol Laboratories, S.A.
- Decision
- Substantially Equivalent
- Date received
- 1976-10-27
- Decision date
- 1976-11-23
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- KSW
- Device class
- 2
- Regulation number
- 864.9145
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.