TAPE-A-TRACE— 510(k) K791892
Substantially EquivalentInstromedix, Inc.
FDA 510(k) clearance K791892 for TAPE-A-TRACE, Substantially Equivalent on 1979-11-05. Applicant: Instromedix, Inc.. Device class: 2.
Clearance details
- Applicant
- Instromedix, Inc.
- Product code
- Code DXM
- Device class
- Class 2
- Regulation
- 21 CFR 870.1450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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