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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories To Examination Light
510(k) Number K131338
Device Name DERMA HOOD
Applicant
Globalmedia Group, LLC
15020 N. 74th St.
Scottsdale,  AZ  85260
Applicant Contact NICHOLAS CAMPBELL
Correspondent
Globalmedia Group, LLC
15020 N. 74th St.
Scottsdale,  AZ  85260
Correspondent Contact NICHOLAS CAMPBELL
Regulation Number880.6320
Classification Product Code
PEQ  
Date Received05/09/2013
Decision Date 07/10/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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