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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K926380
Device Name ALTA DRESSING FRAME
Applicant
Alta Medical Products, Inc.
8378 Azul Way
Sandy,  UT  84093
Applicant Contact WARREN HANSEN
Correspondent
Alta Medical Products, Inc.
8378 Azul Way
Sandy,  UT  84093
Correspondent Contact WARREN HANSEN
Regulation Number880.5090
Classification Product Code
KMF  
Date Received12/22/1992
Decision Date 08/06/1993
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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