BIPURE 1000— 510(k) K912347
Substantially EquivalentLaser Engineering, Inc.
FDA 510(k) clearance K912347 for BIPURE 1000, Substantially Equivalent on 1991-09-23. Applicant: Laser Engineering, Inc.. Device class: 2.
Clearance details
- Applicant
- Laser Engineering, Inc.
- Product code
- Code FYD
- Device class
- Class 2
- Regulation
- 21 CFR 878.5070
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milford, MA, US
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