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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K060488
Device Name DERMATECH IV HOLDER
Applicant
Dermatech Medical, Inc.
102 Heritage Ave.
Castle Rock,  CO  80104
Applicant Contact GLENN THIBAULT
Correspondent
Dermatech Medical, Inc.
102 Heritage Ave.
Castle Rock,  CO  80104
Correspondent Contact GLENN THIBAULT
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
KMK  
Date Received02/24/2006
Decision Date 06/08/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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