HI-69E, HI-69N, HI-69P— 510(k) K974129
Substantially EquivalentRockwin Corp.
FDA 510(k) clearance K974129 for HI-69E, HI-69N, HI-69P, Substantially Equivalent on 1997-12-12. Applicant: Rockwin Corp.. Device class: 1.
Clearance details
- Applicant
- Rockwin Corp.
- Product code
- Code ESD
- Device class
- Class 1
- Regulation
- 21 CFR 874.3300
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dekalb, IL, US
Recent devices under product code ESD
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