Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
FDA 510(k) clearance K151123 · decided 2016-03-03
Clearance details
- K-number
- K151123
- Device name
- Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
- Applicant
- Pac-Dent International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-04-28
- Decision date
- 2016-03-03
- Days to decision
- 310 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
- Brea, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.