BOUNDARY PROCESS CHANGE
FDA 510(k) clearance K821564 · decided 1982-07-02
Clearance details
- K-number
- K821564
- Device name
- BOUNDARY PROCESS CHANGE
- Applicant
- The Buckeye Cellulose Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-05-25
- Decision date
- 1982-07-02
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- FYA
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- 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.