BIPURE 1000
FDA 510(k) clearance K912347 · decided 1991-09-23
Clearance details
- K-number
- K912347
- Device name
- BIPURE 1000
- Applicant
- Laser Engineering, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-05-28
- Decision date
- 1991-09-23
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- FYD
- Device class
- 2
- Regulation number
- 878.5070
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Milford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.