HYDROGEL-PREP— 510(k) K791726
Substantially EquivalentSpenco Medical Corp.
FDA 510(k) clearance K791726 for HYDROGEL-PREP, Substantially Equivalent on 1979-11-20. Applicant: Spenco Medical Corp.. Device class: 1.
Clearance details
- Applicant
- Spenco Medical Corp.
- Product code
- Code NAB
- Device class
- Class 1
- Regulation
- 21 CFR 878.4014
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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