ULTRATHERM (908)— 510(k) K964083
Substantially EquivalentSie-Med, Inc.
FDA 510(k) clearance K964083 for ULTRATHERM (908), Substantially Equivalent on 1997-04-03. Applicant: Sie-Med, Inc.. Device class: 2.
Clearance details
- Applicant
- Sie-Med, Inc.
- Product code
- Code IMJ
- Device class
- Class 2
- Regulation
- 21 CFR 890.5290
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Clarksville, MD, US
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