UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope— 510(k) K183263
Substantially EquivalentUnipack Medical Corporation
FDA 510(k) clearance K183263 for UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope, Substantially Equivalent on 2019-06-14. Applicant: Unipack Medical Corporation. Device class: 2.
Clearance details
- Applicant
- Unipack Medical Corporation
- Product code
- Code PEM
- Device class
- Class 2
- Regulation
- 21 CFR 878.4370
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Fe Springs, CA, US
Recent devices under product code PEM
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