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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Intravascular Catheter Securement
510(k) Number K924249
Device Name DERMASSIST TRANSPARENT SITE DRESSING
Applicant
Wilshire Medical Products
11420 Mathis Ave.
Dallas,  TX  75234
Applicant Contact PRISCILLA WHITEHEAD
Correspondent
Wilshire Medical Products
11420 Mathis Ave.
Dallas,  TX  75234
Correspondent Contact PRISCILLA WHITEHEAD
Regulation Number880.5210
Classification Product Code
KMK  
Date Received08/24/1992
Decision Date 02/03/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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