BIOJECTOR 2000 MODEL 1B02000— 510(k) K960373
Substantially EquivalentBioject, Inc.
FDA 510(k) clearance K960373 for BIOJECTOR 2000 MODEL 1B02000, Substantially Equivalent on 1997-03-05. Applicant: Bioject, Inc.. Device class: 2.
Clearance details
- Applicant
- Bioject, Inc.
- Product code
- Code KZE
- Device class
- Class 2
- Regulation
- 21 CFR 880.5430
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portland, OR, US
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