HYPERFREE— 510(k) K913527
Substantially EquivalentKist Intl.
FDA 510(k) clearance K913527 for HYPERFREE, Substantially Equivalent on 1992-01-21. Applicant: Kist Intl.. Device class: 1.
Clearance details
- Applicant
- Kist Intl.
- Product code
- Code BYO
- Device class
- Class 1
- Regulation
- 21 CFR 868.5220
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lewiston, ME, US
Recent devices under product code BYO
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