UTK-DTE AUTILARY SHIELD— 510(k) K954146
Substantially EquivalentMallinckrodt Medical
FDA 510(k) clearance K954146 for UTK-DTE AUTILARY SHIELD, Substantially Equivalent on 1995-12-06. Applicant: Mallinckrodt Medical. Device class: 1.
Clearance details
- Applicant
- Mallinckrodt Medical
- Product code
- Code KPY
- Device class
- Class 1
- Regulation
- 21 CFR 892.6500
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St Louis, MO, US
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