GC OPB-100— 510(k) K080724
Substantially EquivalentGC America, Inc.
FDA 510(k) clearance K080724 for GC OPB-100, Substantially Equivalent on 2008-06-11. Applicant: GC America, Inc.. Device class: 2.
Clearance details
- Applicant
- GC America, Inc.
- Product code
- Code DYH
- Device class
- Class 2
- Regulation
- 21 CFR 872.3750
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alsip, IL, US
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