510(k) K131338
- Device
- DERMA HOOD
- Applicant
- GLOBALMEDIA GROUP, LLC
- 510(k) number
- K131338
- Product code
- PEQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-07-10
- Date received
- 2013-05-09
- Regulation
- 880.6320
- Classification name
- Accessories To Examination Light
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- NICHOLAS CAMPBELL
- Address
- 15020 N. 74th St. Scottsdale AZ US 85260 85260
FDA Registration Numbers#
- 8040278
- 3009381954
- 1718912
- 3005273623
- 3023808059
- 3029970239
- 3004009431
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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