BLUE SKY BIO TCP— 510(k) K110198
Substantially EquivalentBlue Sky Bio, LLC
FDA 510(k) clearance K110198 for BLUE SKY BIO TCP, Substantially Equivalent on 2011-12-22. Applicant: Blue Sky Bio, LLC. Device class: 2.
Clearance details
- Applicant
- Blue Sky Bio, LLC
- Product code
- Code LYC
- Device class
- Class 2
- Regulation
- 21 CFR 872.3930
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Grayslake, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.