DERMA HOOD
FDA 510(k) clearance K131338 · decided 2013-07-10
Clearance details
- K-number
- K131338
- Device name
- DERMA HOOD
- Applicant
- Globalmedia Group, LLC
- Decision
- Substantially Equivalent
- Date received
- 2013-05-09
- Decision date
- 2013-07-10
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- PEQ
- Device class
- 1
- Regulation number
- 880.6320
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Scottsdale, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.