UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope
FDA 510(k) clearance K183263 · decided 2019-06-14
Clearance details
- K-number
- K183263
- Device name
- UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope
- Applicant
- Unipack Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2018-11-23
- Decision date
- 2019-06-14
- Days to decision
- 203 days
- Clearance type
- Traditional
- Product code
- PEM
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Santa Fe Springs, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.