DEKNA BAND KIT— 510(k) K862115
Substantially EquivalentDeknatel, Inc.
FDA 510(k) clearance K862115 for DEKNA BAND KIT, Substantially Equivalent on 1986-08-19. Applicant: Deknatel, Inc.. Device class: 1.
Clearance details
- Applicant
- Deknatel, Inc.
- Product code
- Code ITG
- Device class
- Class 1
- Regulation
- 21 CFR 890.3025
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Success, NY, US
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