ONE-STEP PLUS— 510(k) K011159
Substantially EquivalentBisco, Inc.
FDA 510(k) clearance K011159 for ONE-STEP PLUS, Substantially Equivalent on 2001-06-08. Applicant: Bisco, Inc.. Device class: 2.
Clearance details
- Applicant
- Bisco, Inc.
- Product code
- Product code EMA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3275
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Schaumburg, IL, US
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