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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K935131
Device Name FAMILY FIRST AID KIT
Applicant
Medical Technologies International, Inc.
26424-200th Ave. SE
Kent,  WA  98042
Applicant Contact CRAIG M MATTHEWS
Correspondent
Medical Technologies International, Inc.
26424-200th Ave. SE
Kent,  WA  98042
Correspondent Contact CRAIG M MATTHEWS
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/28/1993
Decision Date 03/23/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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