SPEC Model M16— 510(k) K150895
Substantially EquivalentSource Production and Equipment Co., Inc.
FDA 510(k) clearance K150895 for SPEC Model M16, Substantially Equivalent on 2015-06-19. Applicant: Source Production and Equipment Co., Inc.. Device class: 2.
Clearance details
- Applicant
- Source Production and Equipment Co., Inc.
- Product code
- Code KXK
- Device class
- Class 2
- Regulation
- 21 CFR 892.5730
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Saint Rose, LA, US
Recent devices under product code KXK
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