Dermadry
FDA 510(k) clearance K192749 · decided 2020-02-10
Clearance details
- K-number
- K192749
- Device name
- Dermadry
- Applicant
- Dermadry Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-30
- Decision date
- 2020-02-10
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- EGJ
- Device class
- 2
- Regulation number
- 890.5525
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Montreal, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.