SCIMED MODEL SC4000— 510(k) K840610
Substantially EquivalentScimed Life Systems, Inc.
FDA 510(k) clearance K840610 for SCIMED MODEL SC4000, Substantially Equivalent on 1984-04-24. Applicant: Scimed Life Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Scimed Life Systems, Inc.
- Product code
- Code DTP
- Device class
- Class 2
- Regulation
- 21 CFR 870.4230
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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