SancDam Latex Oral Dam— 510(k) K212037
Substantially EquivalentSanctuary Health Sdn. Bhd.
FDA 510(k) clearance K212037 for SancDam Latex Oral Dam, Substantially Equivalent on 2022-03-28. Applicant: Sanctuary Health Sdn. Bhd.. Device class: 2.
Clearance details
- Applicant
- Sanctuary Health Sdn. Bhd.
- Product code
- Code MSC
- Device class
- Class 2
- Regulation
- 21 CFR 884.5300
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chemor, MY
Recent devices under product code MSC
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