Advance Medical Designs, Inc. Sterile Ultrasound Gel— 510(k) K163050
Substantially EquivalentAdvance Medical Designs, Inc.
FDA 510(k) clearance K163050 for Advance Medical Designs, Inc. Sterile Ultrasound Gel, Substantially Equivalent on 2017-10-25. Applicant: Advance Medical Designs, Inc.. Device class: 2.
Clearance details
- Applicant
- Advance Medical Designs, Inc.
- Product code
- Code MUI
- Device class
- Class 2
- Regulation
- 21 CFR 892.1570
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marietta, GA, US
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