SAFEWEDGE(TM) RELIEF VALVE DEVICE— 510(k) K912172
Substantially EquivalentSunscope Intl., Inc.
FDA 510(k) clearance K912172 for SAFEWEDGE(TM) RELIEF VALVE DEVICE, Substantially Equivalent on 1991-09-27. Applicant: Sunscope Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Sunscope Intl., Inc.
- Product code
- Code KRB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1915
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westlake Village, CA, US
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More clearances from Sunscope Intl., Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.