PUCK 90M— 510(k) K903576
Substantially EquivalentElema-Schonander, Inc.
FDA 510(k) clearance K903576 for PUCK 90M, Substantially Equivalent on 1990-09-04. Applicant: Elema-Schonander, Inc.. Device class: 2.
Clearance details
- Applicant
- Elema-Schonander, Inc.
- Product code
- Code KPX
- Device class
- Class 2
- Regulation
- 21 CFR 892.1860
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Schaumburg, IL, US
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