DYNEMO 3000— 510(k) K972798
Substantially EquivalentSometec, Inc.
FDA 510(k) clearance K972798 for DYNEMO 3000, Substantially Equivalent on 1998-02-24. Applicant: Sometec, Inc.. Device class: 2.
Clearance details
- Applicant
- Sometec, Inc.
- Product code
- Product code DPW
- Device class
- Class 2
- Regulation
- 21 CFR 870.2100
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stoneham, MA, US
Recent devices under product code DPW
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