SUTURE-AID BOOTIES— 510(k) K832441
Substantially EquivalentOmega-Med Intl., Inc.
FDA 510(k) clearance K832441 for SUTURE-AID BOOTIES, Substantially Equivalent on 1984-03-05. Applicant: Omega-Med Intl., Inc.. Device class: 1.
Clearance details
- Applicant
- Omega-Med Intl., Inc.
- Product code
- Code KDC
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code KDC
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