PLASMA POOLER HEAT SEALER
FDA 510(k) clearance K820301 · decided 1982-04-09
Clearance details
- K-number
- K820301
- Device name
- PLASMA POOLER HEAT SEALER
- Applicant
- North American Biologicals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-02-04
- Decision date
- 1982-04-09
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- KSD
- Device class
- 1
- Regulation number
- 864.9750
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.